The challenge

Pregnancy and early motherhood represent critical windows for health protection, yet only around 5% of medications have been adequately tested, monitored and labelled for use during pregnancy and breastfeeding, while over 90% of women in Europe use medication in this period and more than 70% of medicines carry no pregnancy-specific usage information. The LifeSaver Project is a H2020 project that addresses this major gap. Its ambition is to create a bio digital model of the maternal-foetal interface that enables the safe, high-fidelity testing of pharmaceuticals and chemicals without exposing pregnant women or unborn children to risks.

Approach & results

LifeSaver develops and demonstrates a novel “digitally cloned in-vitro” system for emulating the prenatal conditions around the placental interface. This hybrid bio digital twin system integrates in-vitro microfluidic models with in-silico simulation tools to predict how a substance (drug or chemical) may act as a risk factor for unborn babies. The platform is intended to serve testing and screening needs in the pharmaceutical and chemical industries and to help reduce national healthcare costs through better safety prediction, while also reducing or eliminating animal testing. Within this framework, IDEA Consult led the analysis of the regulatory, standards and market-entry environment required to bring such innovative New Approach Methodologies (NAMs) into mainstream use. Our work ensured that the technological achievements of the project can translate into real-world impact for maternal and foetal health.

IDEA developed a Policy Toolbox designed to accelerate the adoption of NAMs (such as bio digital twins) in regulatory decision-making for medicines and chemicals. This toolbox consolidates actionable recommendations targeted at EU institutions, national regulators, standardisation bodies, industry and healthcare stakeholders, and it serves 2 purposes:

• Promoting the development and regulatory uptake of innovative non-animal testing methods
• Strengthening maternal and foetal health protection by improving risk and safety assessment during pregnancy

How was this Toolbox built? IDEA combined multiple evidence streams to assemble a robust, practice-oriented toolbox:

• Desk research and literature review of EU and international regulatory frameworks
• Interviews across the project’s stakeholder ecosystem, including regulators, industry, clinicians, technology developers and patient advocates
• Participation in specialist workshops and conferences on NAMs, maternal health and regulatory innovation
• Validation interviews with external experts and the project’s EU officer to ensure technical and regulatory accuracy
• Integration of all findings into a structured matrix, later translated into a full written report and targeted recommendations for policy and regulatory communities

What does the Policy Toolbox deliver? The Toolbox identifies gaps and opportunities across the regulatory landscape and proposes concrete levers for change, including:

• Improving regulatory clarity on how NAMs can be used in risk and safety assessments for medicines and chemicals
• Strengthening harmonisation of standards and guidelines, particularly those relevant to maternal-foetal protection
• Supporting validation and acceptance pathways for hybrid in-vitro/in-silico methods like the LifeSaver bio-digital twin
• Encouraging investment and uptake by industry through predictable assessment procedures and clearer market-entry pathways
• Embedding maternal health as a priority in EU safety legislation and research agendas
• Reducing reliance on animal testing in line with EU policy ambitions, by promoting scientifically credible and ethically sound alternatives