Living Impact on Fetal Evolution: Shelter-Analyze-Validate-Empower Regulations

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In Europe about 75% of all neonatal deaths and 60% of all infant deaths occur in infants born preterm, and worldwide 450 neonatal deaths occur every hour. The number of preterm births is growing despite advances in medicine as more pregnancies are in the later age but also due to increasing environmental treats and lack of suitable treatments. In the LIFESAVER vision, every pregnant woman must have a proper living environment with the minimal risks to the fetus, safeguarded with scientifically justified regulations in use and control of potentially risky chemical and medicinal products, leading to healthier quality lives of the babies, overarching for generations. The LIFESAVER addresses the presently unmet societal and healthcare needs in creating and developing of a validated scientific knowledge base for the development and implementation of regulatory approaches relevant to maternal and fetal health. The objective is in creation of new, digitally cloned in vitro system for emulation of the pre-natal conditions in the vicinity of uterine/placental interface, capable of future high biofidelity prediction of safety and risk of substances towards unborn babies. LIFESAVER concept is based on an original idea of hybridization of several innovative technologies, integrating digital in silico/in vitro (biodigital twin) systems, enabling effective screening of chemicals and pharmaceuticals which might affect pregnant women health, reducing animal, preclinical and clinical testing, which is not presently possible with any other existing approaches to the same level of confidence. The outcomes are in design, manufacturing and deployment of a platform having key components of in vitro placental tissue for sufficient emulation of typical prenatal conditions. This aims to provide a solid scientific rationale for new regulations for chemical and pharmaceutical use relevant for the Green Deal vision.