Ruben Rizzi
SVP Global Regulatory Affairs BioNTech
Ruben Rizzi, MD, is Vice-president of Global Regulatory Affairs at BioNTech. He joined the company in December 2019 and has worked on both immuno-oncology and infectious diseases developments. Since early 2020, he serves as global regulatory lead in the team in charge of the development, registration, and lifecycle of the COVID-19 mRNA vaccine co-developed with Pfizer (COMIRNATY). Before joining BioNTech, Ruben covered several areas of regulatory affairs, being responsible for oncology pipelines of small molecules and biologics, hospital anti-infectives, conjugated vaccines, liquid biopsy and IVD platforms, as well as contributing as regulatory and medical expert to pricing and market access initiatives and due diligence processes globally.
Seminars
- Comparing how EMA, FDA, and MHRA currently define and assess mRNA-based therapeutics
- Understanding where regulatory definitions diverge (e.g., biologic vs. ATMP) and how to plan accordingly
- Learning how companies are building global regulatory strategies that reduce friction and misalignment
- Understanding how personalized and patient-specific mRNA products are being approached by EMA and MHRA
- Learning from ongoing oncology-focused mRNA trials navigating the current patchwork of global expectations
- Discussing gaps in guidance for non-infectious mRNA indications and how companies are addressing them
