Kerfuffle! (pt 3)

Chapter 3 of 3. Need to catch up? Read Part 1 and Part 2 of the series.

Formalization of the pharmacometrics process, and the definition of process maps for the key tasks invoked in modeling and simulation activities, can be used for a number of important purposes. (1) They provide a toolkit for governing what is currently considered an ad hoc art form rather than a standards-based scientific endeavor. (2) They define the requirements at the interface of pharmacometrics with upstream and downstream stakeholders in the larger drug discovery/development enterprise. (3) They provide a basis for identifying critical milestones and developing associated performance metrics. (4) They serve as heuristics for scientist engaged in a model building effort and provide a community standard for approaching model complexities and decision-making.

As we move forward with model-based drug development, we can anticipate that the demand for modeling and simulation will continue to increase. Moreover, regulatory submissions will require a deeper level of summarization and synthesis of outcomes across studies for extrapolation and interpolation purposes. In response, pharmacometric models will become more sophisticated, and we will move away from empirical descriptions of exposure-response relationships. These models will require much more attention to study design and data collection strategies that support the models rather than having the model be an afterthought of the current empirical development paradigm.

This transition to model-based development will necessitate important changes that will significantly affect the people, process, and technology currently invoked in performing a modeling and simulation project. No improvement can be expected if we simply increase demands on the existing ad hoc process or rely on symptomatic relief such as hiring additional scientists and support staff. Successfully navigating around these issues will require a rigorous effort to transform pharmacometrics from an ad hoc process to a formal process that is fully integrated into the entire drug discovery/development/commercialization life-cycle.

Thanks for reading. If you thought that was insightful, just wait until you read what we cooked up for our next exciting topic: Square Pegs in Round Holes?