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BioPharma Launch Planning Strategy and Management

In this biopharma launch planning strategy support case study, we explore a project with an early-stage biopharmaceutical company that was looking to become commercially mature and launch their first dermatology product in the U.S. market. Clarkston provided the client with end-to-end support with the help of various subject matter experts to achieve their goals, and the launch planning project was only one piece of the entire puzzle. 

As part of this work, Clarkston supported the client with formulating their launch strategic imperatives and tactical plans that aligned to these strategic pillars specifically for the Chemistry, Manufacturing and Controls (CMC) organization. These tactical plans were built into a comprehensive launch playbook, which was used as the central repository to track and monitor launch progress. One of the critical challenges that the client faced was that the drug product was manufactured by their partner outside the U.S., which meant that they would be able to ship product to the U.S. only after FDA approval, thus delaying their launch (as per their original plan prior to engaging with us).  

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Clarkston provided a unique solution to this challenge, which enabled the client to bring in product to the U.S. two weeks prior to anticipated FDA approval. Clarkston facilitated multiple launch dry runs and working sessions with cross-functional teams internally and with external partners to ensure transparency and accountability. Clarkston also helped the client establish a command center during the week of launch with resources evenly allocated to ensure seamless execution.  

At a time when the new product launch market was as volatile as ever, by partnering with Clarkston, the client was able to launch their first product within 48 hours of FDA approval. Additionally, with the broader array of services Clarkston provided, the client was able to realize their goal of becoming a commercially mature organization.  

Download the full BioPharma Launch Planning Strategy case study here, learn more about our Supply Chain Consulting Services by contacting us below. 

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Contributions from Akar Dalal

Tags: Case Study, Commercial Launch