Michela Gabaldo is Head, Alliance Management & Regulatory Affairs at Fondazione Telethon in Milan (Italy). She is an talented leader and expert in regulatory affairs with more than 20 years experience in drug development . She’s currently supporting the 2 internal Scientific Institutes in Italy, SR-TIGET (San Raffaele-Telethon Institute for gene therapy in Milan) and TIGEM (in Naples) in 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 she’s been actively involved in the development and access of the 1st ex-vivo gene therapy registered worldwide - Strimvelis - in 2016 and in the Libmeldy program who has reached recently the EU approval.
Before joining Telethon in 2011 she has been working in the pharmaceuticals industry for GSK in Clinical Operations and CMC Regulatory Affairs areas for New Chemical Entities (NCE) development.
After graduation in Pharmaceutical Chemistry and Technology, she granted 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’s currently a member of the IRDIRC (International Rare Disease Research Consortium) Therapies Scientific Committee where as core member she has actively contributing to the development of the IRDIRC orphan drug development guide (ODDG).