Optimizing Drug Development: The Role of MIDD and PK/PD Modeling

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 trials.¹ 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, the featured speakers 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.

Register for this webinar to learn how PK/PD modeling can drive smarter decision-making, support regulatory alignment and enhance the efficiency of drug development programs.

1. 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

Speakers

Agnieszka Marcinowicz, PhD, Director, Clinical Pharmacology, Premier Research

Agnieszka Marcinowicz, Director, Clinical Pharmacology, has a PhD in Physical Chemistry with experience in research and drug development, bioanalysis, preclinical studies, clinical development and clinical pharmacology (PK, PD, special populations, etc.). Agnieszka leverages her expertise in PK/PD analysis and modeling, statistical analysis, bioanalysis and nonclinical and clinical drug development to determine and implement unique MIDD approaches for a range of drugs, indications and routes of administration. Agnieszka’s expertise includes designing clinical studies and drafting protocols, conducting PK/PD analysis and writing clinical PK reports, contributing to regulatory strategies for 505(b)(1) and 505(b)(2) drug development, supporting FDA applications and collaborating with interdisciplinary teams to drive successful regulatory submissions and impactful clinical development plans.

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Isaac Asante, PhD, Principal Scientist, Pharmacology, Premier Research

Isaac Asante, Principal Scientist, Pharmacology, is a pharmacist with a doctorate in Clinical Therapeutics and a Master’s in Drug Development and Regulation. He has experience in the various stages of drug development, including biomarker discovery and development, bioanalytical assay development and bioanalysis, preclinical studies, clinical development, data analysis and clinical pharmacology (PK and PD). Isaac provides clinical pharmacology strategies and designs streamlined clinical study programs that facilitate optimized regulatory submissions.

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Jayesh Patel, Principal Scientist, Pharmacokinetics, Premier Research

Jayesh Patel, Principal Scientist, Pharmacokinetics, has a Master’s degree in Pharmacometrics and uses his expertise in pharmacometrics and clinical development to identify and develop a multitude of PK modeling approaches that are fit-for-purpose and drive clients’ projects forward. Jayesh provides hands-on functional expertise in PK/PD modeling and simulation, exposure-response modeling, quantitative clinical pharmacology (PK and PD), data analytics and programming, statistical modeling, traditional non-compartmental PK analysis (NCA) and clinical study requirements and designs and input in regulatory submissions strategies.

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