At the core of every successful launch lies a meticulously crafted plan, a robust governance structure, and expert management of its execution. Last Fall (Three Big Mistakes; September 2024), we delved into the challenges of building an effective launch plan (that crucial 12–18 months before approval) by dissecting common pitfalls that companies encounter, including:

  • Planning in the absence of strategy
  • Overlooking the patient’s perspective
  • Inadequate attention to commercial supply and operations

Today, we shift our focus to the crucial phase of establishing governance, an often overlooked yet integral component of any launch strategy. For some, governance implies too much top-down control, yet structure and process are essential when the ultimate recipient is the patient.

“Governance” refers to establishing the leadership and tactical construct for how the launch team will function. It includes answers to essential questions, such as:

  • Who is on the team, and what role do they play?
  • What are the norms or business rules?
  • How do we communicate?
  • How often do we meet?
  • What is the delegation path when deadlocks occur?

From ensuring clear roles and responsibilities to fostering transparent communication channels, the actions taken during this phase lay the foundation for a seamless launch journey to reach the market and the patients the company hopes to serve.

However, despite its critical role in charting a successful course to launch, many organizations fail to manage governance well (or some don’t manage it at all). With that in mind, today’s newsletter shares three essential strategies for effective governance.

Strategy #1: Build the Team

Companies need to anticipate the time required to plan for governance as part of the launch planning effort.

Prior to forming a launch team, it is important to define the governance structure and roles and responsibilities of those involved in the launch process. Before discussing key elements of the team, it’s worth noting that decisions about membership may require some degree of ruthlessness. Not everyone who wants to be on the team should be included. It’s important to remember that everyone on the team needs to fill a role and have a purpose. Therefore, keeping the team to the right size and organizational level will ensure the launch plan can be managed effectively without the risk of pulling too many people away from the day-to-day work that must be done across the company.

Below are a few recommendations specific to building a launch team:

  • The Launch Team Leader drives the team to execution excellence, addresses resistance, encourages collaboration, and mitigates risks while being a positive rallying force. The value of selecting the right person for this role should not be underestimated as they set the tone for the rest of the team. Choosing someone who understands the importance of defining a compelling direction, establishing a sense of urgency, and celebrating success while instilling accountability will go a long way in developing a culture that balances autonomy and collaboration to achieve success. The leader must also have the trust and confidence of the executive team to make the right decisions along the way.
  • Functional Leads serve as a single point of contact between the launch team and their respective functions. Their responsibilities include defining and maintaining the functional launch plans related to the company-wide plan, participating in launch team meetings, working cross-functionally to progress the plans, and communicating to their sub-teams to ensure launch activities are coordinated and executed as needed.
  • The Project Manager supports the Launch Team Lead in tracking the team’s performance and identifying areas of cross-functional interdependency. We recommend this role be identified early on when the governance plan is being created to weigh in on some of the more logistical considerations that will ensure the plan can be managed effectively. This role will manage whatever tool is selected to track the details, track progress, and inform other processes.
  • A Steering Committee of cross-functional leaders supports the launch team by demonstrating an executive commitment to the project, facilitating strategic decisions, and removing barriers for the team. As the launch is often a long and arduous journey, engaging with the Steering Committee regularly allows them to stay abreast of the latest developments and serves as a facilitator for progress and an ally in the journey.

Strategy #2: Define The Processes

In addition to defining roles and responsibilities and appointing the individuals to the team, time should be spent on defining core processes that will guide the group’s efforts and diminish duplication of effort. The interactions and experiences that occur the first time a group meets are important to set the tone for how the team will function across its lifespan. Team members will quickly assess how the leader will lead and how they will work together. To that end, communicating the importance of individual and team accountability and commitment, plus sharing defined processes to manage and drive progress, will lay a solid foundation for implementing the launch plan.

  • Meeting management will set the stage for the team around expectations. Setting a consistent, regular cadence for meetings that follows a prescribed flow with agendas, pre-reads, and meeting minutes demonstrates a commitment to efficiency and excellence.
  • Decision-making process: A clearly defined and communicated decision-making process and authority level of the launch team provide guardrails to empower the team and drive a sense of ownership. By leveraging the RACI (Responsible, Accountable, Consulted, Informed) model, teams are clear on who needs to be involved in initial decisions/discussions at the tactical level and what needs to be elevated to senior leadership.
  • The plan update process: A launch plan is robust, with as many as 1,000 tactics/activities to be completed over the 18-month period. Careful consideration should be given to the tool that will be used and the process that will be employed to update the plan. By carefully defining the process, the Launch Lead can ensure meetings are focused on critical cross-functional discussions and not spent “babysitting” the team or plan. At The NemetzGroup, we’ve found Smartsheet to be an easy, user-friendly platform that allows the team to communicate updates effectively and efficiently.
  • The escalation process: A best practice for any launch team is to appoint a Steering Committee composed of cross-functional, executive-level leaders to provide strategic direction and serve as the ultimate facilitators of decisions or removers of roadblocks when the launch team is unable to do so itself. Having a Steering Committee committed to the launch effort and available to provide specific program guidance to resolve issue escalations will help ensure plans continue to progress without delays.

Strategy #3: Foster a Collaborative Environment

Creating a cross-functional launch team and collaborative environment with a well-defined governance plan will foster excellence and engagement across the entire effort. It connects all the necessary dots and creates an ecosystem critical to realizing the shared goal. It balances individual and mutual accountability.

Once established, the team ensures launch planning activities align around the strategy, the market, the product, and key stakeholders. Spending time at the start and throughout the launch to ensure those involved are aligned on brand strategy, the go-to-market plan, and their respective roles can save a lot of aggravation and false starts down the road.

With many cross-functional interdependencies, if the team does not work together closely and regularly, significant problems can occur. If not sufficiently engaged, team members may not commit the time and attention to regularly attend meetings and follow through on open action items to advance the plan.

As the team forms and storms, pay special attention to the following pitfalls that may arise:

  • Members of the team who have never experienced a launch may feel overwhelmed. Identifying where additional help is needed and leveraging internal expertise or bringing in experienced contractors/consultants to bridge the gap is essential.
  • Disengagement due to competing priorities. Team members must remain aware of interdependencies and understand the impact of missed deliverables on the larger team. Meetings should include robust and transparent discussions regarding identification of roadblocks and progress towards launch.
  • Leadership micromanagement. Teams need the freedom and authority to make decisions. Gaining alignment prelaunch on roles and responsibilities of leadership and who owns the decision goes a long way in avoiding this challenge and will empower the team.

These risks can be overcome by defining the governance plan upfront and establishing the construct for cross-functional communication, teamwork, and a culture of trust. It’s important that the Launch Leader understands these risks and ensures that their style can be adapted to different situations to ensure all team members work in harmony and to the best of their ability.

Final Thoughts

Investing the time upfront to build launch teams carefully and establish how they will work together sets the stage for success. When everyone shares the same goals and expectations are made clear, teams can work smoothly, leaders can guide the way, and decisions can be made more quickly, ultimately resulting in a more seamless launch journey to reach the market for patients to benefit.