We proudly share a first glimpse at the program of our upcoming Annual Symposium. Registration and abstract submission are now open! More information about (nominations for) the Greiner award can be found here.
Make sure to reserve your spot for our upcoming Annual Symposium (10-11 June 2025)! We are happy to share an updated program below, with added speakers and more information on sessions and award opportunities. The deadline for abstract submission has been extended to 25 April (final deadline): submit your work here. Early-bird fees have expired, but if you submit an abstract you can receive a discount that is equivalent to the difference between the regular and early-bird rates.
Met de huidige technologische ontwikkelingen wordt het steeds lastiger om te bepalen of nieuwe biotechnologische toepassingen als GGO-toepassingen gezien moeten worden. Daarbij speelt op de achtergrond steeds de vraag naar de balans tussen het waarborgen van de veiligheid en het faciliteren van innovatie. De COGEM heeft daarom een inventarisatie laten maken van de juridische mogelijkheden om de wet- en regelgeving zo in te richten dat zij beter aansluit bij snelle technologische ontwikkelingen. In het onderzoek zijn twee casestudies verkend, waar regelgeving en technologische ontwikkeling uit de pas lopen. Eén daarvan betreft de ontwikkeling van self-amplifying messenger RNA-vaccins (samRNA-vaccins). Met deze technologie kan een krachtiger vaccin worden gemaakt. Wereldwijd zijn al enkele samRNAs op de markt gebracht. De gewone mRNA-vaccins vallen niet onder de GGO-regelgeving, omdat mRNA niet gezien wordt als organisme en dus ook geen GGO kan zijn. SamRNA-vaccins hebben het vermogen om zichzelf binnen de cel te vermeerderen, maar kunnen zich niet buiten de cel verspreiden. Ze bevinden zich daarmee in een grijs gebied; hoe moet in dit geval het vermogen tot vermeerdering worden geïnterpreteerd bij de definitie van een organisme en daarmee voor de reikwijdte van de GGO-regelgeving? Het rapport analyseert het probleem en brengt mogelijke oplossingsrichtingen in kaart.
Het rapport kan hier gedownload worden (website COGEM).
We would like to share the upcoming RNA Horizons 2025 Therapeutics Symposium, taking place on October 29-31, 2025 in Palermo, Sicily. This premier event is recommended to researchers with an interest in RNA therapeutics. It explores the latest advancements in the field, from established modalities to emerging areas like ASOs and RNA structure-based therapies. Discussions will encompass key trends: pipeline diversification, enhanced RNA modalities, AI integration, and improved delivery technologies. Notably, the symposium will address translating discoveries into viable therapies, exploring commercialization and market access.
Connect with scientists, industry professionals, and investors to shape the future of RNA-based therapies.
This year’s symposium will delve into the following key scientific themes:
RNA Biology and Disease: Exploring the fundamental mechanisms of RNA biology and their implications in various disease states.
RNA Therapeutics Development: Focusing on the latest advancements in the design, development, and optimization of RNA-based therapeutics.
Targeting and Delivery of RNA Therapeutics: Addressing the critical challenges of delivering RNA therapeutics to specific tissues and cell types.
Emerging RNA Technologies: Showcasing cutting-edge technologies and approaches in the field of RNA research and therapeutics.
Clinical Translation and Commercialization: Discussing the path to clinical application and the commercialization of RNA-based therapies.
FAST has collaborated with experts to create a renewed and expanded guidebook for developing Advanced Therapy Medicinal Products (ATMPs) in the Netherlands. Tailored to both academic and commercial developers, the guidebook delivers essential guidance on European and Dutch regulations and provides a roadmap to navigate the complex ATMP development process.
A guide to the ATMP landscape
The guidebook is the result of close collaboration with key partners, including the Dutch Medicines Evaluation Board (CBG), Hollandbio, DARE-NL, VIG, and input from over 25 experts. Building on the foundation of the VIG’s earlier guidebook, this updated and expanded edition integrates the latest insights, regulations, EMA processes, and advances in clinical research. With its practical tools and guidance, the handbook equips developers to handle complex procedures such as marketing authorization and reimbursement applications more effectively.
Patient-centered approach and collaboration
The guidebook underscores the value of early engagement with patient organizations and provides tools to facilitate this meaningful collaboration. It also emphasizes the importance of early engagement with stakeholders, such as the EMA, CBG, and the National Health Care Institute (ZIN). These collaborations contribute to faster patient access to ATMPs and long-term financial sustainability.
Structure of the guidebook
The guidebook is divided into three sections:
Support and advice
Finally, the guidebook includes an overview of available support and relevant legislation. Developers are encouraged to seek advice from experts and centres of expertise, such as FAST and DARE-NL, early in the development process to simplify the path to market and minimize obstacles.
This guidebook is a valuable resource for everyone active in the rapidly growing ATMP sector, aligning with FAST’s mission to accelerate the delivery of innovative therapies to patients. In the spring of 2025, FAST, together with its partners, will host a series of webinars to present case studies and provide deeper insights into various sections of the guidebook.
