By Peter Smith, Senior Vice President, Cello Health Consulting
Launches are hugely significant events in the lifecycle of any biopharmaceutical company. They absorb the whole organisation and require expertise across the entire range of cross-functional activity. From strategy to project management, market access to public affairs, governance to HEOR, they provide an incredibly thorough test of an organisation’s capability. Indeed, the capability of the organisation is arguably the critical success factor influencing launch success; two different companies with the same asset in the same market will produce quite different launch trajectories.
It is difficult therefore to single out the most crucial aspects of launch. Read any article on launch and the chances are it will major on patient-centricity, customer value and the access landscape. These are important topics but tend to be expressed philosophically with few tangible recommendations. At Cello Health we distil launch activity into three categories: Planning, Readiness and Organisation (Launch PRO). Here we focus on practical and often overlooked issues from each area: scenario planning, key performance indicators and the launch team itself.
Scenario planning
Launch planning frequently has to address complex and unpredictable markets. Uncertain regulatory outcomes, rapidly evolving science and changing competitor sets can all conspire to produce a bewildering array of future states that the launch strategy must account for.
Scenario planning is a useful but often underutilised tool that helps to manage this uncertainty. The methodology is simple but powerful. Rigorous desk and customer research into the evolution of the market highlights those dynamics that can lead to the most variable, or concerning, outcomes. A framework is then developed that looks at how multiple dynamics produce a finite number of scenarios. Importantly, those scenarios can then be characterised to provide a tangible and holistic description of different future worlds, including assumptions, customer and competitor behaviours and issues for the product. Common and particularly significant issues can then be addressed by a core strategy, whereas scenario- specific issues can be addressed by contingency plans, triggered according to anticipated market events or trends. Although the world is getting hard to predict, scenario planning can at least account for most of the unknowns.
Key performance indicators
Securing approval for the launch plan frequently occupies a disproportionate amount of the organisation’s time. The extent of leadership scrutiny can mean focus on implementation can take somewhat of a back seat. Launches often become focused more on surviving to the point of launch than the period immediately afterwards. Yet that narrow window can be crucial for rapid course correction. Detailed implementation planning must ‘run through the tape’ and incorporate the 6-12 month period after launch.
Key Performance Indicators are one answer but often remain untracked or the results ignored. Frequently this is because they are not selected properly or they are simply impossible, or too expensive, to measure. A customer survey may have seemed like a good idea at the time, but is less so in the real world of budget and time constraints. As arduous as it might feel, time spent developing KPIs is a good investment. The following five criteria may be helpful.
1. Relevant and measurable: aligned to strategy and key deliverables and measurable at the time or frequency needed
2. Limited number: KPIs can quickly balloon into dozens of metrics – focus on the one or two most important things in each area
3. Lead and lag: consider both input (lead) as well as output (lag) measures so that performance toward the ultimate objective can be tracked and adjusted
4. Agreed and visible: ensure KPIs are understood across the cross-functional team, geographies and through the organisation
5. Accountable: ensure the responsibility for tracking performance versus the KPI rests with a named individual.
The launch team
Nowhere is the excitement and demands of launch felt more keenly than within the launch team itself. It is the locus of all activity and must navigate the long, complex and often stressful road, bearing the demands and expectations of the organisation. The set-up and support of the launch team therefore requires at least as much attention as the important launch strategies and initiatives, with structure, processes and culture all requiring careful thought. The following five areas deserve particular attention:
1. Goal: a unifying objective that brings together and motivates the entire cross-functional team
2. Organisation: core team for strategy, alignment and driving the plan, sub-teams for focus on critical success factors
3. Leadership: mature, inclusive, decisive, cross-functional leadership
4. Time allocation: agreed contribution from functional team members and their managers
5. Support: relief from at least some of the usual organisational burden to focus on launch.
