Pre-Conference Day – Tuesday 4th March 2025Tuesday, 4 March 2025 - CET (Central European Time, GMT+01:00)

This workshop will discuss an overview of the latest European regulatory updates pertaining to the development and commercialization of oligonucleotide-based and mRNA therapeutics. Participants will gain insights into the evolving regulatory landscape and discuss the initial guidelines for wider classifications of RNA-based products, including how the EU has prioritized the development of RNA therapeutics for rare diseases.

This workshop will delve into the critical role of delivery systems in advancing RNA modalities. Participants will explore innovative approaches to ensure targeted and efficient delivery of RNA therapeutics to specific cell types and tissues, addressing key challenges in achieving therapeutic efficacy and minimizing off-target effects.

• The workshop will focus on the scaling of RNA modalities to the Clinic
• Key process considerations will be discussed with focus on optimal process operations, quality, costs, equipment yields
• Developing analytics to support scale-up is critical to support scale up activities from bench to GMP facility and will be discussed

• Insights into Novo Nordisk’ recent acquisition and collaborations in RNA therapeutics
• Deep dive into the Pharma and Biotech views throughout the partnership process
• Life after the acquisition, including lessons learnt and new working dynamics and considerations