Marielle van Hulten | Senior Principle Scientist
MSD

Marielle van Hulten, PhD: Sr. Principal Scientist, Regulatory Affairs Europe Oncology, MSD Marielle obtained a PhD in virology after which she held several academic positions in viral vaccine development in the Netherlands and Australia. In 2007 she joined MSD Animal Health Global Regulatory Affairs Biologicals where she worked on vaccine registrations, with a focus on GMO vaccines. In 2016 she became R&D Lead in poultry vaccine development working on inactivated, self-amplifying RNA and live GMO vaccines. In 2022 she switched to Regulatory Affairs Europe, Oncology where she is responsible for several oncology therapeutic areas and is part of the team working on the development of individualized neoantigen mRNA therapies.

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?

Shirley Hopper, Medical Assessor, MHRA