Michela is Vice President ATMP Global Regulatory Affairs at EVOTEC International where she is responsible to support the teams working on new innovative allogeneic/autologous cells and gene therapies programs to enter the clinical validation.

Michela brings more than 20 years' experience in drug development having worked for almost 10 years for GlaxoSmithKline (GSK) in Clinical Operations and CMC Regulatory Affairs areas for New Chemical Entities (NCE), before joining in 2011 Fondazione Telethon and San Raffaele Hospital (SR-TIGET) to help them in advancing the most important strategic partnerships with pharmaceutical industries. These programs were developed both internally and in partnership with relevant pharmaceutical industries or through start-ups. In her role she’s been actively involved in the development and patient access among other products, also of the 1st ex-vivo gene therapy registered worldwide, Strimvelis in 2016 and of Libmeldy in 2020.

After graduation in Pharmaceutical Chemistry and Technology at the Padua University, she granted a Master Degree in "Regulatory Affairs and Market Access for new chemicals and Biopharmaceuticals" from the UPO University.

Winner of 2017 edition of TopRA Award in the Future category, Michela offers up to date knowledge of the most recent regulations in ATMPs and Orphans. She has been actively contributing to many international initiatives aimed as shaping the regulatory environment for ATMP in EU and she was proposing many initiatives through leading trade organisations to support timely cross-border patient access for ATMP targeting ultra-rare life-threatening conditions.

She’s currently an active member of the IRDIRC (International Rare Disease Reasearch Consortium) Regulatory Scientific Committee and of the ISSCR (International Society for Stem Cell Research) Regulatory Working Group.

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