The launch plan needs to be appropriate to the organization’s situation and phase, Learn, Build, Govern, and Track. It gains detail as the company progresses through the launch stages, ensuring there is enough planning to help inform strategic decisions and spending. As commercialization nears thirty-six months, more detailed plans help ensure appropriate market shaping and insight development at the right time. The essential components of a launch plan are launch management, launch readiness assessment, and launch summit.
Having a plan to check against and drive timely decisions critical to launch management. When working on a drug launch, you need to have structure and process so that the 10-20 teams involved stay aligned. This usually consists of a governance structure that can help fortify alignment between the teams and keep the communication and information flowing.
This central governance team will develop the launch plan and strategy, outlining critical activities and timelines. The governance structure and team are crucial to ensuring these interdependent activities are aligned. This allows launch teams the ability to accelerate and de-risk the launch. Managing this plan and the operational support team ultimately guides decision-making during launch execution.
Launch Readiness Assessment
Before launching and after communicating the plan and process to all the stakeholders, it is time to assess launch readiness.
A Launch Readiness Assessment includes six key areas:
- Market access
- Supply chain
Many organizations assess their commercial readiness via a launch simulation exercise. This two-day off-site gathers diverse stakeholders, including the brand team, market access, sales leadership, medical affairs, regulatory, global, and a handful of other cross-functional teams. Groups are assigned to companies/brands already on the market in the same area/space as their product or treatment.
On Day 1: we assume the role of the established player and come into the meeting having completed a couple of hours of pre-work (read the PI, market share and volume data, payor landscape, etc.). An example of a scenario for simulation: how to anticipate and react to another brand’s launch, e.g., what would be said promotionally, what tactical levers would be pulled, and what should be done from a rebating standpoint.
On Day 2: we put our own brands’ hat back on and say, “OK, if the ‘other brand’ is going to do/say XYZ, we need to be prepared to counter with ABC.” The workshop helps to pressure test how competitive the commercial space is, how entrenched current competitors are, and the importance of existing brands to their respective portfolios.
When in Launch Mode, it’s easy for companies to focus solely on the “Days to Launch” countdown clock and not look at their blind spots. The launch simulation exercise forces companies to look at the market through an objective, competitive lens.
The objective of holding a launch summit is for all the stakeholders in the cross-functional teams to share recent developments and data to align all the teams on current assumptions. This helps validate and inform adjustments to the launch plan.