Translational Project Management & Regulatory Affairs

Michela Gabaldo

Michela Gabaldo

Location: DIBIT1 A2, Floor 2, Room 33

Head, Translational project management and regulatory affairs

Michela is a talented leader expert in regulatory affairs with more than 20 years of experience in drug development, spanning from new chemical entities up to advanced therapies (gene therapy in particular). She is currently supporting two Scientific Institutes in Italy, SR-Tiget (in Milan) and TIGEM (in Naples) providing global strategic direction in regulatory affairs for the progression of gene therapy (ex-vivo and in-vivo) and gene editing projects tackling rare genetic disease at different stages of development, spanning from research and pre-clinical up to patient access. These programs are developed both internally and in partnership with relevant pharmaceutical industries or through start-ups. Within this role, Michela has been actively involved in the development and access of the first ex-vivo gene therapy registered worldwide - Strimvelis - in 2016 and in the Libmeldy program, which has reached EU approval at the end of 2020.

Before joining Fondazione Telethon in 2011, she has been working in the pharmaceutical industry for GlaxoSmithKline (GSK) in Clinical Operations and CMC Regulatory Affairs areas for New Chemical Entities (NCE) development. After graduating in Pharmaceutical Chemistry and Technology, she earned a Master Degree in Regulatory Affairs and Market Access for NCEs and Biopharmaceuticals. 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 is currently a member of the IRDIRC (International Rare Disease Reasearch Consortium) Therapies Scientific Committee, where as core member she has actively contributed to the development of the IRDIRC orphan drug development guide (ODDG). Due to the peculiarity of the Strimvelis drug, over the last 5 years she acquired an in-depth knowledge of the different legal frameworks leading to the EU cross-border patient access.