Question

You are managing a pharmaceutical product launch project using a hybrid approach. Clinical trials and regulatory submissions follow a stage-gate predictive model due to FDA requirements, while the marketing campaign and digital presence are developed using Scrum. The regulatory team has just learned that the FDA will require an additional study, delaying approval by 9 months. Meanwhile, the Scrum team has completed the e-commerce platform, mobile app, and digital marketing materials scheduled for the original launch date. The program sponsor is concerned about losing competitive advantage and wants options for generating value from the completed digital work. What is the MOST appropriate strategy?

Accepted Answer

Work with the Product Owner and marketing leadership to identify interim value opportunities such as launching educational content, building community engagement, or piloting in markets with different regulatory requirements while maintaining compliance with FDA restrictions on product claims

Answer

Release all completed digital assets immediately to establish market presence and brand awareness, then add disclaimers that the product is pending FDA approval to manage legal risks

Answer

Redeploy the Scrum team to other projects until the regulatory approval is obtained, then bring them back for launch preparation in the final quarter before the new approval date

Answer

Pivot the Scrum team to begin working on next-generation product features and enhancements that will be ready for a major update shortly after the delayed launch, maximizing the development window

PMP Practice Question: Process — Hybrid, Hard

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