Presenting MHRA’s Perspectives & Draft Guidance on the Licensing of Individualised mRNA Cancer Immunotherapies
Time: 4:15 pm
day: Day 1 PM
Details:
- Individualised mRNA cancer immunotherapies (cancer vaccines) pose new regulatory challenges since the mRNA sequence is matched to the patient’s unique tumour neoantigen profile and HLA type
- The MHRA aims to publish draft scientific and regulatory guidance for developers of individualised mRNA cancer vaccines by the end of 2024. This will include sections on regulations, manufacturing, non-clinical, clinical and post-authorisation aspects
- An overview of the key points will be presented
