Michel Hauser | Nonclinical Assessor, ATMP Division
Swissmedic

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

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

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...

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Michel Hauser, Nonclinical Assessor, ATMP Division, Swissmedic

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

Michel Hauser, Nonclinical Assessor, ATMP Division,
Swissmedic

Michel Hauser is a nonclinical assessor working in the Advanced Therapy Medicinal Product division at Swissmedic. Michel is part of the group that develops Swissmedic’s internal evaluation process on individualised mRNA cancer immunotherapies.

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Marielle van Hulten, Sr Principle Scientist, Regulatory Affairs Oncology, MSD, MSD

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

Marielle van Hulten, Sr Principle Scientist, Regulatory Affairs Oncology, MSD,
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...

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Ruben Rizzi, SVP Global Regulatory Affairs, BioNTech SE

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

Ruben Rizzi, SVP Global Regulatory Affairs,
BioNTech SE

Ruben Rizzi, physician by training, SVP of Global Regulatory Affairs at BioNTech. I joined the company in December 2019 just before the pandemic, and I have been the global regulatory lead for BioNTech for our COVID-19 development. Currently, I am still supporting the lifecycle of our COVID-19...

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