Alicja Fiedorowicz

Alicja Fiedorowicz, MSc, is an Associate Director, CMC with over 14 years of professional experience in the development and CMC regulation of biological products and advanced therapies. She has extensive experience with regulatory submissions and interactions with health authorities across the USA, EU and UK. Her expertise spans allogeneic and autologous genetically modified cell therapies, viral vectors including LV, AAV and Adenovirus, as well as plasmids, mRNA, CRISPR-Cas systems and various biologics. She has technical expertise in analytical development, quality control, product and process characterisation, comparability evaluations, and process and analytical validation. Alicja has written and reviewed regulatory documentation, including MAA/BLA/IND/CTA submissions and scientific advice briefing packages. She regularly presents at scientific conferences and participates in expert groups, sharing insights on technical challenges and CMC strategies for advanced therapies. Her prev