Panel Discussion: Navigating Evolving Regulatory Expectations as mRNA Moves Beyond Vaccines

• Clarifying EMA & MHRA expectations for mRNA drug substance, drug product, biodistribution, toxicology & immunogenicity as therapeutic applications diversify
• Understanding how regulatory requirements differ across vaccines, protein replacement, oncology, gene editing & other emerging mRNA applications
• Addressing the regulatory classification of mRNA products, including where non-genome-altering mRNA and mRNAenabled gene editing fit within existing frameworks
• Keeping pace with evolving global guidance while identifying where RNA-specific regulatory expectations remain unclear

Speakers:

Abhi Kavathia

Associate Director GMP/CMC Drug Product

BioNTech

Alejandro Barquero Lemus

Regulatory Affairs Manager

Almirall