Go global: planning for the global and regional nuances of commercialization in biotech

For Biotech companies the US and EU markets are key to the commercial potential of novel products, particularly specialty and orphan therapeutics. The US remains the largest single market by value for pharmaceuticals with the EU (plus UK), accounting for approximately one-fifth of the global market.

However, many global commercial product launches have underperformed, particularly for first commercial biotechs. The differences in reimbursement and commercial launch needs across the EU and US markets present unique challenges to emerging biotechs who are often launching products while simultaneously building their global, regional, and in-country commercialization organizations. Often referred to as “building the plane while flying it” this simultaneous orchestration of clinical and regulatory strategy while ideating and realizing commercial strategy and build-out is challenging for lean, frequently single-country-headquartered companies.

In order to adequately address these commercial challenges companies must build upstream commercial insights into earlier-stage planning both in clinical program design as well as in their operational buildout. Failing to source and integrate these global commercial implications early in launch preparedness and clinical program design is a common impediment to achieving commercial launch expectations and, in today’s lean operating environment, is a challenge for executive leaders to adequately resource early in company lifecycle.

Sam Falsetti, Global Chief Biotechnology Officer at Inizio Medical explores some of the key considerations for emerging biotech in planning for effective global and regional product launches.

Bringing real-world insights into early-stage planning

The clinical program, and resulting product profile, is a key pillar in launch planning. Having deep insight into target markets, reimbursement pathways, and likely real-world medical utilization early in the product profile and clinical program planning is critical to setting and meeting commercial launch expectations. For lean organizations, establishing these insights without a large, potentially premature, expansion of headcount requires developing relationships with external partners, including key opinion leaders, data providers, and consultancies. These insights will fuel both clinical program design as well as operational planning and key accessory programs, such as Real World Evidence (RWE) and Health Economic Outcomes Research (HEOR) development.

Integrating global and regional planning

The old adage “think globally and act locally” is certainly true but we should emphasize that “thinking globally” requires understanding and integrating regional insights within this global framework. Orchestrating against this challenge without an in-market footprint requires global leaders to either have regional-level and in-market expertise or supplement with expertise through a combination of market research and flexibly sourced subject matter experts.

Typically, the most important strategic areas for launch planning include key differences in potential real-world utilization and the complexities of payor and health system differences across key geographies. In particular, the complexities of navigating the US healthcare system with a complex mix of government, private, managed care, and state-related payors, as well as private, non-profit, and academic-affiliated health centers, is a key feature of planning. For the EU, this complexity is diffuse given the large number of markets to consider, each with different health technology assessments, payor models and reimbursement pathways.

Operationally, having a well-informed global and regional strategic launch plan is critical to determining the operational build-out model. Pairing operations and strategy through an analytics framework are important qualitative guides and can also provide validation of both launch strategy and operational frameworks. This can include market assessments, audience profiling, and KPI development. Similar to strategic planning, bringing in subject matter experts within each vertical is key to successful analysis, planning, and budgeting but is often required before a seminal hire within each vertical can take place. This challenge places additional stress on global leaders who must figure out ways to source expertise early in the planning process.

Inizio: solutions that maximize asset value at every opportunity

Inizio Biotech was created specifically to provide global and regional solutions for biotechnology firms. We have constructed our network with the strategic and operational challenges in mind with early access to practice-level leads within each vertical and downstream agency support for pre-launch and launch execution needs. Our solutions network development was rooted in our array of experiences partnering with biotech leaders from their first commercial launch through to franchise growth and global build out over the last twenty years.

We believe that every day is an opportunity to help you nurture and build toward the true value of your asset. Providing best-in-class medical services and strategic guidance across your clinical development and commercialization journey, our biotech solutions guide, validate, and inspire the decisions that will maximize the value of your assets globally and regionally. Find out more: http://www.inizio.health/biotech