Pre-Conference Day – Tuesday 4th March 2025 - CET (Central European Time, GMT+01:00)
This workshop will provide an in-depth 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.
- Shirley Hopper - Deputy Director National Licensing Strategy, MHRA
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.
- Marty Koser - Head of Platform Innovation, Global Nucleic Acid Therapies Research, Novo Nordisk
- Manuel Vega - CEO, AGS Therapeutics
This workshop will address the challenges and opportunities associated with scaling up the production of RNA modalities for clinical use. Participants will discuss strategies for achieving cost-effective manufacturing, developing sustainable processes, implementing green processes such as enzymatic use and ensuring consistent quality control throughout the production pipeline.
- 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
- Karina Thorn - Corporate Vice President, Head of Research, Global Nucleic Acid Therapies Research, Novo Nordisk