Engineering a Pharmacometrics Enterprise

A pharmacometrics enterprise must efficiently develop, effectively disseminate, and reliably maintain accurate and complete explications of the determinants of drug effects that stakeholders can use to improve the decision-making processes. To create such a enterprise requires three elements. The first is the infrastructure - the data definitions and assembly processes that will allow efficient pooling of data across trials and development programs. The second is the process itself - developing guidelines for deciding when and where modeling and simulation should be applied and criteria for assessing performance and impact. The third element concerns the organization and culture - the establishment of truly integrated, multi-disciplinary and multi-organizational development teams trained in the use of modeling and simulation in decision-making. Systems engineering can play an essential role in integrating these three elements into an enterprise that satisfies the needs of its stakeholders.