Alejandro Sanz Garcia | PKPD modeler
LYO-X AG

Alejandro Sanz Garcia is an expert for the PK/PD and QSP supported development of antibody–drug conjugates, T cell engagers, cell therapies, and other advanced modalities across multiple therapeutic indications. He focuses on leveraging preclinical data to enable safe first-in-human and efficacious dose predictions, as well as supporting clinical development using quantitative approaches. He holds an MSc in Biotechnology from ETH Zurich, with a specialization in computational immunology.

Appearances:

Festival of Biologics Day 1 @ 13:30

First in Human Dose Selection for ADCs and TCEs Using PK/PD and QSP

First-in-human dose selection remains one of the highest-stakes decisions in oncology drug development—particularly for complex modalities such as Antibody-Drug Conjugates (ADCs) and T-cell Engagers (TCEs). Misjudging this step can lead to delayed development, unnecessary patient risk, and significant value loss.

In this workshop, LYO-X presents an integrated, model-informed strategy to de-risk and accelerate FIH dose prediction. For ADCs, the focus is on translating preclinical data into a robust understanding of therapeutic dose and window. For TCEs, the challenge lies in identifying a starting dose that is both safe and sufficiently close to pharmacological activity, minimizing dose-escalation steps and avoiding subtherapeutic exposure.

By combining in vitro and in vivo preclinical data with advanced PK/PD and quantitative systems pharmacology (QSP) modelling, LYO-X demonstrates how to generate data-driven, decision-ready dose recommendations. The session will highlight how this approach enables more confident clinical entry, optimizes trial design, and ultimately accelerates time to proof-of-concept.

Matthias Machacek, Managing Director, LYO-X AG