Project description
Closing the gap in prenatal drug safety research
Drug safety in pregnancy is one area that still constitutes a major blind spot in the field of medicine. Pregnant women have to take crucial decisions on issues related to their well-being in cases where limited information is provided on the impact of a certain medication. This is because most medications are not tested on pregnant women. In order to address this issue, the ERC-funded PROTECT project aims to develop a new means of assessing the safety of medications used by pregnant women. A novel approach is necessary due to the fact that pregnant women cannot be involved in clinical trials, while animal research proves ineffective in this respect.
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.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences basic medicine pharmacology and pharmacy drug discovery
- medical and health sciences basic medicine pharmacology and pharmacy drug safety
- social sciences economics and business business and management business models
- medical and health sciences clinical medicine obstetrics
- medical and health sciences basic medicine toxicology
You need to log in or register to use this function
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
-
HORIZON.1.1 - European Research Council (ERC)
MAIN PROGRAMME
See all projects funded under this programme
Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-ERC-POC - HORIZON ERC Proof of Concept Grants
See all projects funded under this funding scheme
Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) ERC-2025-POC
See all projects funded under this callHost institution
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
20133 Milano
Italy
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.