Prenatal Risk Of Toxicity Evaluation for Clinical Translation

Objective

Drug safety during pregnancy remains one of the most underexplored and high-risk areas in medicine. Pregnant women are routinely excluded from clinical trials, and animal models often fail to predict human outcomes, leaving a critical blind spot in assessing fetal drug toxicity. As a result, many therapies are withheld during pregnancy due to insufficient safety data, not demonstrated harm, creating both a medical and societal gap. PROTECT proposes the first clinically adaptable, high-throughput 3D-bioprinted in vitro platform to evaluate drug toxicity on human fetal tissues during mid-to-late gestation. The system leverages prenatal cells combined with advanced bioprinting to create reproducible 3D tissue models enabling systematic testing under conditions compatible with pharmaceutical and regulatory workflows. The project will pursue three technological objectives: (1) optimize a robust 3D-bioprinting protocol to ensure reproducibility and scalability; (2) develop a functional testing pipeline using benchmark compounds to validate predictive value; and (3) upscale the model to achieve the throughput required for industrial use. In parallel, a business validation track will analyze stakeholder needs, market dynamics, regulatory frameworks, and alternative business models (product sales, testing-as-a-service, licensing). This will ensure that PROTECT is not only scientifically robust but also aligned with user requirements and positioned for commercialization. By bridging a long-standing gap in prenatal toxicology, PROTECT aims to deliver safer and more inclusive drug development, reduce reliance on animal testing, and prepare the ground for a dedicated spin-out company capable of driving clinical and industrial adoption.