Business situation: Evaluate build v. buy manufacturing capabilities to support products under a Biologics License Application (BLA).
The approach: Developed a flexible decision model comparing the economics of building manufacturing capabilities to support BLA products v. outsourcing. Decision model had more than 100 inputs, including several sales forecasts, internal/external costs, as well as FDA approval likelihood and timing. Each input could be analyzed independently to determine its impact on the outcome.
Business outcome: The model was vetted by Deloitte without any major revisions. The outcome of the model was used to determine best path for the business (buy). $25M decision.
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