Developing a Commercial Systems Capability Roadmap for a Clinical-Stage Biotech Company
In this Commercial Systems Capability Roadmap case study, a client was evaluating whether to outsource commercial capabilities or build them in-house to ensure they were equipped for scale as they launch additional therapies globally. This client is a clinical-stage immune-oncology organization focused on developing therapeutics to address the unmet needs of patients with various forms of cancer sought assistance to prepare for its transition from clinical to commercial. The client is based in Europe with several therapies in phase 1/2 trials with one therapy expected to launch in the U.S. within a year.
The business model decision was informed by overall commercial strategy, financial return on investment, and minimal viable product (MVP) systems capability requirements to maintain regulatory compliance. The senior leadership team was in the process of positioning their commercial model strategy with the Board of Directors and seeking a partner who could advise and develop capability roadmaps based on the commercial model scenarios that were in consideration.
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Clarkston’s Commercial Launch Advisory team was engaged to recommend systems capabilities across 10 functional areas to ensure preparedness for commercial operations. The team conducted a series of interviews to understand business requirements and their alignment to the overall commercial model strategy. Once capability requirements and current state assessment was completed, Clarkston completed a prioritization exercise across 36 systems capabilities within 10 functional areas to illustrate what systems were required to mitigate risk or ensure ownership of data and reporting in line with business requirements. The prioritized capabilities were then charted on a roadmap based on resource availability, implementation timing, dependencies, and compliance measures to ensure readiness for commercialization at time of anticipated product launch. As a result, the client received two roadmaps to use as a foundation for continued operations and systems implementation planning activities as they finalized their commercial model strategy.
