LifeSaver is based on an original idea of hybridization of several innovative technologies, integrating digital in silico/in vitro (biodigital twin) systems
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 the creation of a new, digitally cloned in vitro system for emulation of the prenatal conditions in the vicinity of the 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.
Challenges & Objectives
The overall objective of LifeSaver is to create and demonstrate, within 48 months, a new, digitally cloned in vitro system for emulation of the prenatal conditions in the vicinity of placental interface, capable of high biofidelity (BiFi – a measure of the level of how well the artificial system is able to replicate the functionality of an organ or body rather than mimicking its structure and anatomy), and corresponding risk predictions of a drug or a chemical substance as a potential harmful risk factor towards unborn babies, with all these features to be compatible and feasible for improvement of the respective regulations.
To achieve the objectives within the timeframe of the project, LifeSaver focuses on the detailed and relevant analysis of the placental tissues barrier functions but not addressing maternal/fetal ADME (adsorption, distribution, metabolism, excretion) mechanisms, toxicology neither teratogenicity, genotoxicity etc. as they will require specific and separate studies for every chosen compound.
The added value of LifeSaver in the spirit of the Green Deal call is in scientifically-based tool for experimental screening and digital pre-screening and analysis of chemicals and pharmaceuticals on their potential to cross placental tissues barriers, which will provide rationale for existing and new compounds risk classification, regulations and risk assessment/mitigation measures justification towards potential effects of these compounds on pregnant women and fetal health.