Product Launch and the Strategies, Processes, and Operations of Medical Affairs to Support Start-Up Companies
Tóm tắt
For a launch of the first product by a start-up company, the medical affairs (MA) team plays both strategic and operational roles. Launch presents a brand-new and urgent situation at a company with limited experiences, staff, and budget. A structured set of processes for analysis, planning, implementation, and follow-up are cited to assist a start-up in this new endeavor. This article discusses the why, what, how, when, and by or for whom questions a new MA department must consider in the launch phase. External audiences for the company and MA include investigators and customers (providers and institutions). At a start-up company, the research and marketing divisions, the internal customers of MA, need bridging for optimal periapproval strategy. A strategy and plan for MA are required to be integrated with corporate, product, and research strategies. Many options for MA exist and will depend on existing people (experiences and biases), corporate and product strategies, budget, systems availability, and target audiences. Priorities need to be set among the many possible programs, such as phase 4 trials, medical information, publication strategy, formularies, thought-leader development, and adverse experience reporting. Another strategic question is whether to outsource, use corporate staff, or develop corporate alliances to fulfill the responsibilities. Phase 4 research is discussed as a capstone to integrate all the aforementioned issues.
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