Nicholas Valiante

The regulatory landscape for mRNA is changing and becoming increasingly complex with new products now entering clinical phase trials from novel cancer vaccines to unique protein replacement therapeutics. Drug developers remain without clarity on how their pipeline will make it, without a clear regulatory consensus or guidelines.

This workshop will feature experienced regulatory submission tried-and-tested strategies for maximizing your speed to clinic.

This workshop will address:

• How does regulatory strategy differ for a vaccine versus therapeutics?
• How much data and quality of data is required to secure approval for different modalities and indications?
• Is there a strategy for gaining accelerated approval once you’re in the clinic leveraging your platform?

Case studies include:

• From Pandemic Urgency to Inter-Pandemic Normalcy: How the Regulatory Landscape has Evolved for mRNA Products