Shirley Hopper | Medical Assessor
MHRA

Dr Shirley Hopper worked as a general practitioner in the NHS before moving to the MHRA 17 years ago. Previously, Shirley sat on the EMA pharmacogenomics working party and contributed to guidelines on pharmacogenomics and biomarkers. Shirley has led on national licensing strategy including the MHRA's new national assessmnet procedure. Currently, Shirley works as a medical assessor in the vaccine and ATMP team within the biological products unit, where she leads on the MHRA's draft guideline on individualised mRNA cancer immunotherapies which was published for consultation earlier this year.

Appearances:

Day 3 - Thursday 16th October @ 13:30

Regulating Personalised mRNA Cancer Immunotherapies: AI Innovation vs Regulation, Global Impact and Industry Readiness

How will MHRA’s classification of these therapies as ATMPs impact global regulatory alignment?
What are the key risks of AI performance drift and bias in personalised therapy development?
How will classifying algorithms as SaMDs shifting AI-driven selection to an IVD regulatory framework disrupt existing trial, manufacturing and quality control models? Should AI-driven neoantigen selection be classified under IVD regulations, or should it remain part of GMP-regulated manufacturing?
What industry best practices exist for balancing regulatory compliance with the rapid release of individualised therapies?

Ruben Rizzi, SVP Global Regulatory Affairs, BioNTech SE