Selecting an appropriate first-in-human (FIH) dose is a pivotal step in successfully translating innovative therapeutic modalities such as antibody-drug conjugates (ADCs), bispecific antibodies, fusion proteins, gene therapies, antisense oligonucleotides (ASOs) and combination treatments into clinical development.

Traditional dose selection approaches often fall short in addressing the unique pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of these modalities, increasing the risk of suboptimal efficacy or safety concerns.

The primary focus of this workshop will be on integrated PK/PD modeling–driven approaches combining in-vitro and in-vivo data, mechanistic insights, and translational strategies to optimize first-in-human dose selection, de-risk early clinical trials, and support regulatory interactions. We will illustrate how these methods extend beyond defining a safe starting dose by enabling prediction of clinically effective doses, onset of action, and duration of treatment effects. Ultimately, this approach supports the design of FIH studies that go beyond safety assessment, enabling efficient dose escalation with a well-justified dose range and study duration, and facilitating a seamless transition to dose-finding studies or even directly into 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.

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.