MEB Science Day 2025 - Platform Technologies: opportunities and challenges
Join us for the MEB Science Day 2025, a unique opportunity to share knowledge and connect with colleagues in the field of regulatory science. This year’s event will take place on Monday 19 May 2025, from 12:15 to 18:00 at Tivoli Vredenburg, Utrecht.
Why Platform Technologies?
Platform technologies have recently gained increased attention due to their potential to advance medicines development. A growing number of vaccines, antisense oligonucleotides and advanced therapy medicinal products (ATMPs) are being produced using platform technologies. Recent developments underscore their importance:
- In April 2023, the European Commission proposed new pharmaceutical legislation for human medicines introducing platform technology as a novel approach to approve medicines with both a fixed and variable component (Article 15 of the draft Directive).
- In 2024, the United States Food and Drug Administration (FDA) launched its Platform Technology Designation programme.
During the event, we will explore three distinct concepts of platform technologies, and their opportunities and challenges:
- Platforms for medicinal products manufactured using prior knowledge, such as common manufacturing platform approaches (multiple marketing authorisations);
- Platforms for medicinal products against agents which are or have a potential to cause serious cross-border threats to health e.g. pandemic/pandemic preparedness (one marketing authorisation);
- Platforms for the manufacture of personalised or individualised medicines (‘one patient/group of patients-one product’, one marketing authorisation) e.g. covering different ultra-rare orphan indications.
We will dive into questions, such as: What establishes a platform? What are the advantages of platforms? Are platforms sufficiently adaptable? What can we learn from the implementation of the vaccine platform technology master file for veterinary medicines? What are the opportunities for n-of-1 therapies, i.e. an individualized therapy developed for and used by one or very few people living with a rare disease?
Poster sessions, panel discussion and networking opportunities
In addition to insightful presentations and discussions on platform technologies, the MEB Science Day will also highlight research conducted within PhD trajectories in which the MEB is involved. Eighteen PhD students will present their posters, showcasing work on topics ranging from the 3Rs and biomarkers to real-world data.
We look forward to welcoming you on 19 May 2025 in Utrecht! Registration is open:
