Pre-Conference Day - CET (Central European Time, GMT+01:00)
This workshop will focus on the practical realities of scaling chemically synthesized RNA from laboratory to GMP manufacturing without compromising cost, timelines or capacity. It introduces a practical 4-level maturity model to help organizations assess scale-up readiness and identify critical gaps before committing to expensive GMP campaigns.
Key Topics:
- Critical failure points in RNA scale-up
Common stumbling blocks moving from mmol to multi-kg scale.
- The RNA scale-up maturity model
A 4-level framework (Lab-centric - Process-aware - Transfer-ready - Commercial) to guide progression from bench to scalable manufacturing.
- Cost of goods & yield – the hidden killers
How strategical and technical choices directly impact campaign economics and timelines.
- Analytics, impurities, and control strategy
A phase-appropriate analytical approach to reduce GMP risk.
- Building Flow Without Building a Factory
Manufacturing flow, CDMO alignment, and governance considerations.
- Interactive Q&A / Discussion
- Sonja Merkas, PhD - Founder, Creator and Doer, Livinovea
This workshop will explore targeted delivery strategies for antisense oligonucleotides (ASOs), siRNA, and next-generation mRNA therapies, with a focus on applications in key tissues and organs such as the liver, lung, kidney, brain, and heart. Participants will examine innovative approaches to achieve precise delivery to these critical sites, addressing challenges in overcoming biological barriers, enhancing therapeutic efficacy, and minimizing off-target effects.
- Dominik Witzigmann - CEO, Nanovation Therapeutics
- Hani Najafi - Assistant Professor of Cell and Developmental Biology, Cornell University
This interactive workshop will guide biotech management teams through a practical framework for approaching valuation in strategic partnering situations, from assessing core asset attributes to understanding how negotiation dynamics and deal terms shape perspectives value. Participants will explore how scientific differentiation, development stage, risk profile, and commercial potential translates into intrinsic value assumptions, and how partnering structures, market dynamics and other external factors may influence headline value and partner alignment.
- Renee Williams - Founder & Managing Partner, Williams Biotech Consulting
- Jeff Raphael - Founder & Managing Partner, OmniScope Partners
