Leaning on exosomes, model-informed drug development gets closer to tailoring doses to each patient

How liquid biopsies could lead to the next big step in modeling dose levels for precision medicine.

Model-informed drug development is poised to move into personalized dosing, with a little help from exosomes. An August FDA workshop aims to shed light on when and how to use these precision dosing models in clinical trials and real-world settings.

The workshop is part of FDA’s dual commitments to promote use of model-informed drug development (MIDD) and real-world evidence (RWE) under PDUFA VI (see “Model Alliance”).

Drug developers are increasingly turning to MIDD to help design dosing strategies. The process involves computationally simulating physiological processes in the human body, such as drug transport into tissues or binding to target proteins, to enable more accurate predictions of drug activity than traditional allometric scaling of animal data (see “Model Firsts”).

But most models either assume patients are all the same or put them in broad categories, based on a limited set of physical metrics or genetic variants.

The next iteration of MIDD, model-informed precision dosing (MIPD), personalizes the process further by incorporating a suite of parameters, such as a patient’s age, size, comorbidities and biomarkers, to predict variability in drug responses and create individualized dosing regimens.

“The precision dosing we’re talking about is knowing precisely what we should be giving

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