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.
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.
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
An alliance launch
Internal pressures and external needs
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:
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.
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
2. Understanding the true barometer of the launch—the voice of the people
–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
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.
Vynamic, an Inizio Advisory company, is a leading management consulting partner to global health organizations across Life Sciences, Health Services, and Health Technology. Founded and headquartered in Philadelphia, Vynamic has offices in Boston, Durham NC, and London. Our purpose is simple: We believe there is a better way. We are passionate about shaping the future of health, and for more than 20 years we’ve helped clients transform by connecting strategy to action.
Through a structured, yet flexible delivery model, our accomplished leaders work as an extension of client teams, enabling growth, performance, and culture. Vynamic has been recognized by organizations like Great Place to Work and Business Culture Awards for being leaders and innovators in consulting, company culture, and health. Visit Vynamic.com to discover how we can help transform your
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