Press release from Malta Innovation Hub, 22 November 2023
Digital Placenta On-a-chip: Malta is partnering in EU funded research to help pregnant women minimise risks to the fetus from potentially harmful chemical and medicinal products.
The Malta Innovation Hub at the Malta Life Sciences Park hosted the LIFESAVER consortium partners of the Horizon funded project for the LIFESAVER conference. The LIFESAVER Project is to reduce neonatal and infant death rates in Europe. Across 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 threats and lack of suitable treatments.
The Hon. Minister for Active Aging Jo-Etienne Abela opened the conference. Mr Abela, a Consultant Laparoscopic and Endoscopic Surgeon by profession is also responsible for the Malta Medicines authority. Mr. Abela noted that the European Medicines Agency (EMA) relies on the results of clinical trials to authorise medicines in the European market. Although clinical trials are authorised at national level, EMA plays a key role to develop innovative clinical trials. In the EU approximately 2,800 clinical trials are authorised each year where 40% of such clinical trials are carried out by noncommercial sponsors, mainly academia. Innovative technologies, as presented by the LIFESAVER project, should have the possibility of also addressing standardisation concerns in obtaining consistent results in clinical trials.
Ing Joseph P Sammut Director at the Malta Innovation Hub and founder of the Malta Life Sciences Park
Ing Joseph P Sammut Director at the Malta Innovation Hub and founder of the Malta Life Sciences Park welcomed the other partners and organised a pre-conference tour of the Park operated by the Malta Enterprise and explaining future expansion plans that consist of a private Advanced Medical Centre across the road from Malta’s general hospital Mater Dei where further research similar to the LIFESAVER and other clinical trials can take place.
Professor Micheal Gasik, the LIFESAVER Project leader, explained that the project is demonstrating an innovative digitally cloned in-vitro system to simulate the prenatal conditions and risk prediction of the drug or a chemical substance towards unborn babies. Pregnant women can suffer from many conditions that require continuous or acute treatments, but they also suffer from environmental pollutants such as chemicals, contaminants, cosmetic products and foods.
Professor John Joseph Borg, from the Malta Medicines Authority and European Medicines Agency noted that, at the moment, the only conclusive process to ensure the safety and efficacy of a biomedical product is to test it on humans through clinical assessment. Unfortunately, due to unknown and potentially harmful effects of testing products on the developing foetus, only below 1% of all clinical trials in consider pregnant women.
The new technologies being developed by the LIFESAVER project intend to propose alternative options to human clinical assessment. They include a combination of nano-technology, artificial intelligence, micro-fluidics and 3D bio-printing to create a Digital Placenta On-a-chip. The discussion between the project scientists and the stakeholders present explored the opportunities in the complex clinical trial European directives where the LIFESAVER technologies can be beneficially applied to make pharmaceutical products better and safer for pregnant women and their
LIFESAVER partners tour the cell culture labs at the University of Malta
The LIFESAVER partners were afterwards invited to tour the cell culture labs at the University of Malta used for growing different primary cells. Professor Pierre Schembri Wismayer explained how this research can only be done in a willing 3-way collaboration with the Department of Health and Mater Dei Hospital primarily by addressing GDPR concerns with the patients and their guardians to utilise tissues that would otherwise be disposed. Professor Schembri Wismayer also introduced the
licensed spin off lab DenovoCell which is working on innovative techniques to produce induced PLuripotent stem cells. The LIFESAVER partners subsequently also visited the Mater Dei Hospital.
The innovative digital biotechnologies as presented by the LIFESAVER intends that every pregnant woman must have a proper living environment with minimal risks to the foetus by addressing the testing limitations set by the current regulations. The project is demonstrating a high accuracy in risk prediction of drug or chemical substance towards unborn babies. The resulting LIFESAVER technologies will present a major step ahead in improvement of the European healthcare and environment.
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Read more about this project here.