Kerfuffle! (pt 2)

Chapter 2 of 3. Need to catch up? Read the previous post in the series.

But where do kerfuffles come from and how do we prevent them from happening? The current processes for implementing a pharmacometric analysis have, for the most part, developed spontaneously from the ad hoc application of modeling and simulation activities. Historically, these applications have been selected based on the inclinations of individual drug development team leaders, and the result has been the lack of a formal connection to the larger drug development enterprise. The importance of modeling and simulation in a specific drug development program is often not clear at the beginning of a program when prospective planning can be implemented. The necessary data can be difficult to locate, and often, the key data required for modeling are not available until the traditional efficacy and safety analyses have been completed. The data assembly and scrubbing process can be remarkably time-consuming, even delaying completion of modeling and simulation activities. Further, significant resistance to the use of modeling and simulation findings in decision–making can be encountered because of unfamiliarity on the part of the development team with interpretation of the results and the urgent timelines of the development program. This ad hoc implementation of pharmacometrics and the “crisis” mode under which it frequently operates can obscure the important ways in which the use of modeling and simulation can impact the entire life-cycle of drug discovery, development and commercialization.

These disconnects, generated when modeling and simulation activities are overlaid onto traditional development programs rather than being integrated into them, are an important source of kerfuffles. Although there are many different kinds of kerfuffles, for the most part, they can be traced back to lack of formalization of the pharmacometric process and the lack of well defined relationships with the larger drug discovery/development enterprise. Importantly, kerfuffles act as the “canary in the coal mine” serving as the symptoms of deeper problems. Specifically, kerfuffles provide valuable insight into the unmet processual, informatic, and systematic needs of the pharmacometrics process. As such, kerfuffles play an important role in efforts to improve the quality and effectiveness of modeling and simulation efforts by serving as valuable input for process formalization.

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