Selecting the right first-in-human (FIH) dose is a critical step in translating groundbreaking therapies, such as antibody-drug conjugates (ADCs), bispecific antibodies, immunocytokines, gene therapies, antisense oligonucleotides (ASOs), Fc-fusion proteins, and combination therapies, into clinical success. Traditional dose selection approaches often fall short in addressing the unique pharmacokinetic (PK) and pharmacodynamic (PD) properties of these novel modalities, increasing the risk of suboptimal efficacy or safety concerns.

This workshop will provide a practical overview of FIH dose selection challenges and solutions, drawing from real-world examples and the latest modeling strategies. We will demonstrate how PK/PD modeling can integrate preclinical data, mechanistic insights, and translational approaches to optimize dose selection, de-risk early clinical trials, and support regulatory interactions. Beyond identifying a safe starting dose, PK/PD modeling can also predict clinically efficacious doses, time to onset of effect, and effect duration. In this way, FIH studies will not only be safe but feature an efficient dose escalation with an informed top dose and the right study duration, facilitating a seamless transition to dose-finding studies or even directly to Phase III.

Designed for scientists and decision-makers in preclinical and translational research, this session will offer a clear, strategic framework for using PK/PD modeling to inform FIH study design. Whether you are working on preclinical development, translational strategy, or regulatory interactions, you will leave with actionable insights to enhance decision-making in early-phase drug development.