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Abstract:
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In many situations pharmaceutical sponsors are considering development at risk. One example is having to address multiple stakeholders' requirements, such as regulators and payers. Sponsors' dilemma in this situation is which approach to take to address these requirements, sequential or parallel. In the sequential approach sponsors are focused on addressing regulatory requirements first. Any additional payers' requirements are addressed if and when the regulatory approval is achieved. In the parallel approach sponsors are addressing regulatory and payers' requirements simultaneously, therefore they are developing at risk. We will be using a decision-analytic approach to provide an optimal solution to this problem. We will also present an example to illustrate the optimal solution.
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