How do I plan for a pharmaceutical launch when I don’t have all the answers?
Picture this: you are 3 years out from launching your new pharmaceutical product, and you are responsible as the Commercial Launch Lead. Your company is currently enrolling patients for your Phase III clinical trials, and leadership is starting to ask questions about the launch. Some colleagues feel that it is too soon to start planning and laying the foundations for a pharma launch strategy, given the limited data and information available, the many uncertainties, and numerous other, more immediate priorities. Still, you have a strong sense that you need to make a start…
Is it ever too early to start pre-launch planning?
No, not at all! The earlier you start, the better. Gathering insights takes time, and these insights will be key to informing a successful pharma product launch. Whilst there are a lot of unknown variables, the key message here is that you should not delay your pharmaceutical launch planning until everything is crystal clear. This is the time to start considering what gaps exist and what assumptions, therefore, need to be made until more information and data are available.
Don’t just take our word for it; what does the real-world evidence suggest?
- 80%+ of product launches do not improve on their first 6 months’ performance
- Only 1 in 5 new product launches improve significantly between 6 months and 2 years
- 2/3 of pharmaceutical companies have seen their pharma product launches underperform against analyst expectations
- 50% of pharmaceutical product launches have failed to reach even 50% of external revenue forecasts
These daunting figures very much suggest that the first 6 months of a product launch are critical to success, and this initial stint typically sets the tone for the onward launch trajectory. Therefore, if it is essential to get the first 6 months right, planning and preparedness are more important than ever. Making an early start on pre-launch activities could help you engage healthcare professionals more effectively through training and support, while also enabling you to gather critical data to inform your strategy.
How to start planning your pharma pre-launch activity
You first need to identify and engage your cross-functional launch planning team. The launch team kick-off and early pre-launch activities are critical parts of the launch strategy and help ensure you are equipped to navigate the early commercialisation and launch landscape. This will set the tone and expectations for the launch, enable you to build meaningful differentiation for your pharmaceutical product among healthcare professionals, and ultimately maximise patient benefits.
This is also crucial to ensuring alignment among the cross-functional team. Consider having two launch teams: a core team and an extended team. Who is involved in the core team may change closer to launch, but generally speaking, it is important to engage all functions as early as possible. Don’t forget some of the less obvious roles, too, like packaging, manufacturing, and distribution, which may differ depending on whether you are a global or country launch lead. The cadence of launch planning meetings will be another important element of your pharma product launch strategy and will likely increase in frequency the closer you get to launch.
Setting a target launch date provides an important reference point for the team to work towards. This date can then be used to map out launch milestones by working backwards to highlight key deliverables and the required sequence for launch. A really effective way to do this is to get everyone face to face and map out the timeline up to (and 6 months beyond) launch. Although your current focus is the pre-launch planning efforts for -3 years, it is incredibly reassuring to see the bigger picture. Anyone who feels it is too early to start planning will understand the importance of early preparation after completing this activity.
What are the next steps for your pre-launch activity?
One of the most important factors now is to keep the momentum: ensure each function is clear on its priorities and that these are tracked. We strongly recommend an action plan for the next 4 weeks and the next 3-6 months. This provides a breakdown of activities for everyone to work towards, making the timeline bite-sized and actionable, allowing for easier management. It is also super important to stay together as a pharmaceutical launch planning team, tracking progress across actions and continuing cross-functional discussions with regular touchpoints.
So, with this in mind, how do you plan for launch when you don’t have all the answers?
Assumptions, assumptions, assumptions! The critical activity here is keeping a detailed log of all assumptions and routinely returning to them throughout the launch planning process. Scenario planning and risk mitigation are also critical elements of ensuring a smooth pharmaceutical product launch.
The essential takeaway from this piece is to get comfortable with uncertainty in the knowledge that you have identified your priorities for your current stage of launch planning, you have bite-sized action plans by function to make inroads with launch planning, and all of your assumptions are well-informed and detailed in a log that is regularly returned to, allowing you to base decisions on data.
One final consideration to reassure your planning efforts is to understand what best practice looks like for launch planning at -3 years (as well as up to and beyond launch). How are you tracking against your launch excellence milestones and KPIs? How does your timeline of activities and milestones compare to this? What differences are there in your timeline to best practice, and why? Keeping track of your progress like this can hugely reassure you in your launch planning efforts while also challenging your preconceptions and guiding your next steps.
In conclusion, the key elements to early pre-launch planning include mapping your journey to launch using your target launch date as a key milestone to work towards, understanding where you are at with your cross-functional pre-launch activities, prioritising the gaps in your pre-launch plan, and getting comfortable with uncertainty while capturing and closely tracking assumptions.
Starting early means that you have a robust strategic footing based on insights for launch. You can then continually revisit and adapt your launch plan as new information, data, and insights become available. Successful launch strategies will rely on this foundation of knowledge and preparation, ultimately leading to a successful product that meets the needs of patients and healthcare professionals.
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