July 24, 2025
11 a.m. EDT

With strong support and encouragement from the FDA in recent years, model-informed drug development (MIDD) has become a pivotal strategy for enhancing the efficiency and cost-effectiveness of clinical trials1. MIDD approaches help balance the risks and benefits of drug products in development using a variety of quantitative methods, including pharmacokinetic/pharmacodynamic (PK/PD) modeling.

PK/PD modeling leverages mathematical models to describe the relationship between drug dose, concentration in bodily fluids, drug effect, and time based on nonclinical and clinical data sources in drug development. By utilizing PK/PD modeling and simulation, drug developers can answer a variety of scientific questions, for example how to optimize dosing regimens, adjust dosing in special populations, and assess factors that drive the variability in drug response among individuals. Overall, this strategy enables sponsors to increase the likelihood of study success and guide personalized therapy.

In this webinar, we provide a brief overview of PK/PD modeling, highlight the advantages of using PK/PD modeling and simulation in drug development, and present case studies that demonstrate how MIDD strategies supported key decision-making and streamlining of 505(b)(2) and 505(b)(1) drug development programs.

Attendees will gain insights into:

The FDA’s perspective on MIDD
PK/PD modeling strategies and their benefits
The application of PK/PD modeling and simulation across different drug development pathways

Speakers:

Agnieszka Marcinowicz, PhD, Director, Clinical Pharmacology

Isaac Asante, PhD, Principal Scientist, Pharmacology 

Jayesh Patel, Principal Scientist, Pharmacokinetics

Source:

Lesko, L.J. and van der Graaf, P.H. (2024), Reflections on Model-Informed Drug Development. Clin Pharmacol Ther, 116: 267-270. https://doi.org/10.1002/cpt.3335