Pre-Conference Workshop Day: Tuesday 23rd April

7:30 am Morning Coffee & Registration

8:30 am
Workshop A: Harmonising Process Development & Regulatory Standards to Improve Comparability Changes & Accelerate Routes to Market

  • Monica Dommel Associate Director Regulatory Affairs CMC, CureVacSE
  • Francis Galaway Quality Assessor, Medicines & Healthcare Products Regulatory Agency (MHRA)

Synopsis

Blurred regulatory standards are hindering advancement in mRNA process development, analytical development and manufacturing. With fast-tracked approval for mRNA vaccines previously granted for COVID-19, uncertainty now surrounds the application of mRNA for other disease indications. This workshop will unite key regulatory leaders to shed light onto acceptable regulatory standards and better understand how to tackle them.

Topics include:

  • What are the acceptable quality standards for drug substance and product release?
  • How much we can leverage from previously approved platform technologies to facilitate future regulatory approvals?
  • How can we better comply with regulators to smoothen the CMC process for mRNA platform technologies?

10:30 am Morning Break & Networking

11:00 am
Workshop B: Overcoming the mRNA Sequence Design Problem to Generate RNA Therapeutics with High Manufacturing Efficiency & Biological Activity

Synopsis

Optimising mRNA sequence design is crucial to establish structure and stability of the final mRNA drug substance, which must balance cost and efficacy. Further hurdles include weighing up the factors of an ideal mRNA construct with the importance of manufacturability and the costs of 5’ capping. Join this workshop to explore how the latest advancements will enable the design of stable and efficacious mRNA constructs to facilitate manufacturability of next generation therapeutics.

Join this workshop to learn:

  • How to secure the optimal mRNA construct tools to maximise efficacy and stability?
  • How to balance efficacy and stability of an mRNA construct with its manufacturability to deliver on production and reduce costs?
  • Understand which computational tools can be leveraged in mRNA design to facilitate and reduce bottlenecks of downstream processes
  • How to tackle bottlenecks in the 5’ capping process to boost mRNA stability?

1:00 pm Lunch Break & Networking

2:00 pm
Workshop C: Innovating Platform Technologies to Work with Non-Traditional RNA to Facilitate their Application for Therapeutics

  • Chijian Zuo Vice President, SuZhou CureMed Biomedical Technology Co. Ltd
  • Bas Spaans CMC Scientific Integrator Drug Substance Development, Janssen R&D

Synopsis

Next-generation RNAs, such as circular and self-amplifying RNA, are driving advances in the field to alter drug delivery times and improve molecular stability and safety whilst reducing cost of production and manufacturing. Here, the bottleneck of integrating into current process development platforms and the risk of potential downstream effects will be navigated to better understand how to tackle integrating new platforms to aid the application of non-traditional RNA types for therapeutics.

This workshop will answer:

  • What are the upstream and downstream considerations when working with non-traditional RNA types to optimise their process development?
  • How to navigate the development of new platform technologies for process development of non-traditional RNA types to facilitate their approval and bring next-generation RNA therapeutics to market
  • How do differing therapeutic indications non-traditional RNA type impact process development and manufacturing?

4:00 pm End of Pre-Conference Workshop Day