Elevate your pharmaceutical launch strategy: The COE advantage

With contributions from: Chris Cubra

Launching a new drug in the U.S. is a complex, multifaceted challenge. From numerous stakeholders to the need for cross-functional alignment and the pressure of tight timelines, bringing a new product to market is a significant undertaking. Whether you are launching your first drug or planning multiple launches over the next 36 months, a launch center of excellence (COE) can bolster your organization’s readiness for a product’s launch.

What is a launch COE?

A structured launch COE is an integral part of an organization’s approach to introducing new products. It anchors best practices, champions consistent launch excellence strategies, and establishes consistency in execution for maximum launch impact. A launch COE’s services can encompass early-stage strategic planning, providing insights into launch preparation best practices, through to launch execution. Additionally, a COE equips organizations with best-in-class operational tools to monitor and manage launch progress.

By centralizing expertise, resources, and best practices, a COE offers a cohesive platform to kickstart launch planning and amplify launch strategies. It can offer a framework and tools for streamlining communication and planning efforts, reducing risk and expediting decision-making. A launch COE serves as the hub that increases the likelihood of a successful product launch by optimizing planning, enhancing collaboration, and executing launch planning effectively.

The COE’s value proposition and organizational considerations

Launch COEs aim to refine and streamline the processes of launch governance, communication, and execution. This enables teams to focus on their core priorities, all while following a familiar and tested pathway for introducing products or indications to the market. Thus, launch COEs deliver consistent execution and establish critical measures of success in alignment with overarching launch objectives and the expectations of leadership.

The value of a launch COE grows as an organization matures and diversifies in the marketplace. Whether through acquisition or home-grown studies, first-time launch teams often face challenges in maximizing their market potential while striving to meet the goals of both internal and external stakeholders.

While almost every organization could benefit from a launch COE, the following criteria stand out as the primary situations in which organizations should strongly consider implementing a launch COE model:

Upcoming multiple indications/launches

• More than one US and/or Global launch planned in the next 36 months.
• Multiple drug or indication launches approaching in a short period of time.

An alliance launch

• Internal or external partners on a launch.
• Unclear ways of working, roles and responsibilities, operational standards, or planning milestones.

Internal pressures and external needs

• Multiple launches in the pipeline with uncertain or variable timing that could benefit from a flexible staffing approach.
• Lack of internal resources and/or expertise in launch leadership, execution, planning, or capabilities.
• Need for standardized approach, tools, and processes to streamline launch experience and performance.
• Pressure to execute a flawless launch with ambitious goals and high stakeholder expectations (typically given negative feedback or performance below expectations on a previous launch).
• Seeking to grow organizational acumen and maturity around launch excellence.

The COE structure and archetypes

All organizations encounter a similar set of internal and external challenges when launching a new drug or indication. While these pressures are alike, organizations have unique circumstances and opportunities that influence how a launch can be staffed, managed, and executed. These circumstances lead to different COE models tailored to an organization’s needs. Key factors to consider when evaluating launch COE models include organizational maturity, institutional knowledge, previous launch experience, and team culture.

There are several types of COE models that organizations can evaluate to determine the best fit:

• Outsource – This COE model is characterized by fully outsourcing the launch COE responsibilities and operations to experienced strategic partners. The Outsource COE model provides execution and economic benefits including immediate access to experienced individuals, adaptability in start timing, cost efficiency (reduced operational and administrative costs compared to staffing a full-time employee), and the flexibility to scale resources as launch needs evolve.
• Internal – This COE model utilizes a company’s existing experience to help build a launch COE for launch planning for a particular product. The benefits of this model include fostering the development of in-house capabilities to provide long-term value, easier cultural alignment and integration, and greater control over strategic decisions, processes, and quality. While it might necessitate a higher initial investment, the organization can often leverage external strategic consulting support to stand up the COE prior to internal teams being hired.
• Hybrid – This COE model involves a combination of internal employees and experienced external strategic partners to collaborate and execute the launch COE. This model’s benefits include leveraging combined expertise, optimizing flexibility, and encouraging knowledge transfer. This model typically requires a higher level of investment than a fully outsourced model.

Selecting between COE models depends on an organization’s unique objectives, resources, and nature of the launches. While a hybrid model may often balance control and flexibility, allowing a launch team to leverage external expertise while maintaining core competencies in-house, there is no one-size-fits-all answer. It is essential to continuously evaluate and adapt the COE’s operating model as an organization evolves and project requirements change.

Planning for impact and measuring success of a launch COE

A launch COE provides full spectrum strategic oversight, from early launch planning to comprehensive launch execution, while utilizing best-in-class operational tools and industry-leading insights. This consistent and collaborative approach to launch excellence and delivery enables critical therapies to be brought to market safely and expeditiously.

When it comes to readiness and implementation, there are three areas that organizations should evaluate to measure the success of a launch COE:

1. Clearly defined measures of success

• The first element in determining success is, of course, defining clear measures of success. Every launch and organization are different, so defining and aligning KPIs for the launch team and launch COE is the first prerequisite.

2. Understanding the true barometer of the launch—the voice of the people

• It is important to collect quantitative and qualitative feedback throughout the launch journey from the teams diligently preparing for a launch; you must understand their experience and the support they received through the COE. The COE is successful if teams are leveraging the knowledge and experience of the COE, they are confident in the launch plans, and leadership is bought in.
• A team’s culture is paramount to success as it must allow them to maintain the positive energy, focus, and drive to bring a product to market. Key areas that are critical success factors for team culture include:

–Shared values and alignment to strategy
–Clear roles, responsibilities, and goals
–Quality resourcing/dedicated teams
–Culture of partnership, collaboration & inclusivity
–Culture of transparency & accountability
–Culture of innovation
–Empowered decision makers
–Senior level leadership sponsorship & accessibility

3. Retrospective review against launch objectives

• It is important to ensure that lessons learned are captured, shared internally for other launch teams, and built into launch best practices to improve future launches.

The Vynamic value for your launch COE

Creating a launch COE provides your product with the best chance of success and serves as an institutional investment that enables greater strategic go-to-market strategies. With Vynamic’s extensive client experience and launch work, our teams have accessible subject matter experts and best practices readily available to ensure that your launch COE can excel from its inception.

More than 125 Vynamic team members have supported a product launch, serving on 450+ product launch engagements (including 40+ new-to-market products) across 60 therapeutic areas. We have partnered with over 37 diverse pharmaceutical and biotech clients with U.S., global, and alliance launches. Our experts can work closely with you to create a tailored COE model to achieve your organization’s vision of launch success.

Learn more about Launch Centers of Excellence and Vynamic’s Product Launch offerings, and contact us to discuss how our team can support your strategic launch initiatives.