The EU-funded ERAMET project is setting a new standard for the development of orphan and paediatric medicines. With an innovative approach that blends advanced modelling and simulation techniques with real-world data, ERAMET aims to create a transparent ecosystem to benefit both medicine developers and regulatory authorities. This will enable faster and more effective decision-making processes, ultimately speeding up the development of essential medicines for vulnerable patient groups.

At the heart of this ambitious endeavour is the ERAMET consortium, comprising 17 partners from seven European countries: Belgium, Norway, the UK, Italy, Spain, France, and the Netherlands. Each partner brings their own unique expertise, spanning across key areas such as regulatory science, computer modelling and simulation, data science, bioinformatics, artificial intelligence (AI), machine learning (ML), digital twins, clinical trials, and drug development.

The consortium includes key players in the regulatory landscape:

• UNamur, SRLAB, FAMHP, UV, CBG, UMCG, ANSM, and AEMPS feature current or former (vice-)chairs and members of EMA committees or working parties.
• Four partners—FAMHP, CBG, AEMPS, and ANSM—serve as European National Competent Authorities, lending their regulatory expertise to ensure compliance and streamlined processes.

On the drug development side, ERAMET is supported by seven key partners:

• Five SMEs—Aparito, CERTARA, CVBF, FGB, and Aridhia—and two academic groups—UNICT and UCL—ensure that perspectives from both industry and academia are integrated.
• AI and ML are crucial to ERAMET’s approach, and three partners—Aridhia, the University of Warwick, and Aparito—are leading the way in applying these cutting-edge technologies to drug development and assessment.

By integrating these diverse areas of expertise, ERAMET promises to revolutionize the way orphan and paediatric medicines are developed. The project’s ultimate goal is to make the development process faster, more efficient, and more transparent, thereby bringing vital treatments to patients in need more quickly.

Stay tuned as the ERAMET project continues to unfold and redefine the future of medicine development in Europe.