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Using real-world data for post-market surveillance of drug safety

After a therapeutic drug hits the market, it is crucial to continuously gather, analyze, and report data regarding its safety and potential side effects, a practice known as pharmacovigilance. Unlike clinical trials, this involves real-world data (RWD), presenting unique challenges in terms of both quality and quantity. The Belgian BELpREG project seeks to employ RWD for monitoring drug utilization during pregnancy and investigating potential safety implications for both maternal and child health. This initiative holds great promise, although it faces substantial hurdles on its path to success.
Muna Therapeutics is developing transformative therapies for neurodegenerative diseases. These drugs aim to preserve cognition and enhance the brain’s resilience in diseases like Alzheimer’s and Parkinson’s, providing much-needed hope for millions of patients and their loved ones.
BioWin and MEDVIA are two Belgian organizations which support and promote health innovation in Wallonia and Flanders. This year, these two clusters have come together to jointly organize the event Science for health on the topic of ‘biology meets technology’. In this dual interview, Ann Van Gysel (MEDVIA) and Sylvie Ponchaut (BioWin) discuss the differences between their regions and how they are working to improve cross-border collaboration in Belgium.
The AIPLANT project aims to reduce complications from dental implant surgery using AI-based preoperative planning. The project is a collaboration between the Centre for Dentomaxillofacial Imaging at UZ Leuven, AI startup Relu, and Xentro Dental. 
Agomab Therapeutics NV (‘Agomab’) today announced the closing of a $100 million (€94.9 million) Series C financing round led by Fidelity Management & Research Company, with participation from new investors EQT Life Sciences (EQT), Canaan, Dawn Biopharma, a platform controlled by KKR, and existing investors.
This year, Science for health will explore the inspiring innovations at the interface of biology and technology. The event will bring together academics, industry leaders, and policymakers to explore the newest treatment platforms and factories of the future. BioVox spoke to Werner Verbiest, member of the event’s Scientific Committee, about the topic and why collaboration is so key right now.
After an exceptional sequence of socio-economic shocks over the past few years, the number of new companies being formed in key European biotech hubs has stalled. Early-stage investors need to roll up their sleeves and help to crank the engine of EU innovation back to life.
Studies of a drug's effectiveness and safety don’t end with clinical trials – they extend beyond market access when the true value of a drug is demonstrated in a real-world setting. Based on this information, factors such as availability, pricing, and reimbursement are adjusted. To study the actual worth of a treatment, we require real-world data (RWD) from a large and diverse patient population. By actively sharing this information with stakeholders, we can fuel further research and innovation, and even help to inform decision-making on a population level. But in order to unlock the full potential of our patient data, all members of the ecosystem have to work together.
AstroCardia has developed a heart-on-a-chip to study cardiovascular aging… in space! Trials will begin in 2025 aboard the International Space Station (ISS). The MEDVIA project was made possible thanks to the combined expertise of the five Belgian partners: Space Applications Services, the Belgian Nuclear Research Center (SCK CEN), QbD Group, BIO INX, and Antleron.
  • Fields of application

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  • Regional News

After a therapeutic drug hits the market, it is crucial to continuously gather, analyze, and report data regarding its safety and potential side effects, a practice known as pharmacovigilance. Unlike clinical trials, this involves real-world data (RWD), presenting unique challenges in terms of both quality and quantity. The Belgian BELpREG project seeks to employ RWD for monitoring drug utilization during pregnancy and investigating potential safety implications for both maternal and child health. This initiative holds great promise, although it faces substantial hurdles on its path to success.
Muna Therapeutics is developing transformative therapies for neurodegenerative diseases. These drugs aim to preserve cognition and enhance the brain’s resilience in diseases like Alzheimer’s and Parkinson’s, providing much-needed hope for millions of patients and their loved ones.
BioWin and MEDVIA are two Belgian organizations which support and promote health innovation in Wallonia and Flanders. This year, these two clusters have come together to jointly organize the event Science for health on the topic of ‘biology meets technology’. In this dual interview, Ann Van Gysel (MEDVIA) and Sylvie Ponchaut (BioWin) discuss the differences between their regions and how they are working to improve cross-border collaboration in Belgium.
The AIPLANT project aims to reduce complications from dental implant surgery using AI-based preoperative planning. The project is a collaboration between the Centre for Dentomaxillofacial Imaging at UZ Leuven, AI startup Relu, and Xentro Dental. 
Agomab Therapeutics NV (‘Agomab’) today announced the closing of a $100 million (€94.9 million) Series C financing round led by Fidelity Management & Research Company, with participation from new investors EQT Life Sciences (EQT), Canaan, Dawn Biopharma, a platform controlled by KKR, and existing investors.
This year, Science for health will explore the inspiring innovations at the interface of biology and technology. The event will bring together academics, industry leaders, and policymakers to explore the newest treatment platforms and factories of the future. BioVox spoke to Werner Verbiest, member of the event’s Scientific Committee, about the topic and why collaboration is so key right now.
After an exceptional sequence of socio-economic shocks over the past few years, the number of new companies being formed in key European biotech hubs has stalled. Early-stage investors need to roll up their sleeves and help to crank the engine of EU innovation back to life.
Studies of a drug's effectiveness and safety don’t end with clinical trials – they extend beyond market access when the true value of a drug is demonstrated in a real-world setting. Based on this information, factors such as availability, pricing, and reimbursement are adjusted. To study the actual worth of a treatment, we require real-world data (RWD) from a large and diverse patient population. By actively sharing this information with stakeholders, we can fuel further research and innovation, and even help to inform decision-making on a population level. But in order to unlock the full potential of our patient data, all members of the ecosystem have to work together.
AstroCardia has developed a heart-on-a-chip to study cardiovascular aging… in space! Trials will begin in 2025 aboard the International Space Station (ISS). The MEDVIA project was made possible thanks to the combined expertise of the five Belgian partners: Space Applications Services, the Belgian Nuclear Research Center (SCK CEN), QbD Group, BIO INX, and Antleron.