Transitioning to a commercial-stage company Making the transition to a commercial-stage company requires the establishment of a wide range of new operational and supply chain capabilities. A pre-commercial biopharmaceutical company focused on metabolic genetic disorders had rapidly built a diverse portfolio of late-stage product candidates and was anticipating its first market introductions within the next 18-24 months. The company was experiencing typical clinical-stage company challenges as it relates to supply planning: Planning was manual, people-dependent, and suffered from a lack of formal standards Communication between impacted organizations was informal and event-based making planning assumptions and parameters unclear and insufficiently transparent Manufacturing and supply lea

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