Diana Gershtein, M.Sc., M.B.A.

Regulation and Advanced Therapies Section Manager

Ms. Gershtein holds a Bachelor's degree (B.Sc.) in Biology from the Technion – Israel Institute of Technology, and Master's degrees in Biology (MSc) and Business Administration (Executive MBA) from Haifa University, Israel.

Diana has 14 years of diverse experience in the Advanced Therapies industry (cell and gene therapy, regenerative medicine) with a considerable knowledge in Regulatory Affairs, development, pre-clinical and clinical studies design, GMP manufacturing and Quality Assurance.

At her former position at MultiGene Vascular Systems (MGVS), Diana has overseen clinical cell therapy product manufacturing in Israel and the USA, established a quality system suitable for multi-center clinical manufacturing, developed operational and logistics programs for advanced-phase clinical studies and played a key role in regulatory affairs with the FDA and EMA.

At Gsap, Diana serves as the Advanced Therapies Section Manager. Gsap has worked until today with more than 25 cell therapy and gene therapy companies/products in Israel and abroad, at different stages of product development, starting from early proof of concept, through pre-clinical and clinical stages.

At Gsap Diana led projects for the following companies: Pluristem Therapeutics, Kadimastem, Bonus BioGroup, CellCure Neurosciences, Sheltagen, Betalin, BioGenCell, Accelta, Immuno-Therapy laboratory (Tel Aviv Sourasky Medical Center), Cytora, Brainstorm, CTG, Exostem, KidneyCure, Minovia Therapeutics, BM transplantation unit at Tel Aviv Sourasky Medical Center, Precise Bio, AVROBIO and CAR-T cells units at Tel-ha-Shomer, Tel Aviv Sourasky and Hadassah Medical Centers).

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