Clarkston recently partnered with a clinical-stage biopharmaceutical company to develop a global supply chain commercialization roadmap. This company designs transformative medicines to treat patients who suffer from genetic diseases and cancers.
The client is filing for an NDA (New Drug Application) in 2023 and preparing its supply chain to go commercial in 2024, which will be quickly followed by submission in Europe for approval to sell in key markets. In advance of their planned commercial filing, the client needs to evolve their supply chain capabilities to support a global commercial operation and wants to leverage current clinical supply chain practices and avoid unnecessarily “reinventing the wheel.”
The client needed to understand the gaps between current capabilities and the capabilities needed for a commercial entity, considering aspects of the “process, people, and technology” framework. They engaged Clarkston to help realize these capabilities and develop a two-year commercialization roadmap.
Clarkston’s approach to the project began with conducting interviews and visioning exercises with key stakeholders. Clarkston then performed a current state gap analysis to determine the framework needed for commercial supply chain readiness. This approach allowed Clarkston to better understand the strategic approach and impacts of clinical and commercial timelines. Clarkston identified over 25 capabilities the client would need to develop for long-term success and future global supply chain stability. In consideration of these new capabilities, Clarkston was able to build a supply chain roadmap for short- and long-term planning and develop a supply chain strategy activation plan needed for a robust commercial supply chain.
Clarkston helped the client understand the impact of implementing these capabilities on the organization’s people, processes, and technologies. This provided the client with a path forward in evolving and preparing their supply chain to go commercial in 2024.