(i) Design of in-vivo pre-clinical studies in accordance with scientific papers, regulatory guidelines, intended clinical indication and type of product,

(ii) Design of preclinical strategy for regulatory submissions, including identification of gaps in the existing data,

(iii) Review and preparation of preclinical protocols, reports and documents for regulatory submissions (e.g., Investigator brochure), and

(iv) Oversight of preclinical study performance at the selected CRO.

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Michal was awarded a DVM degree from the Hebrew University’s Koret School of Veterinary Medicine, in 1997 and had a long and successful career at HBI Biotech (former Envigo CRS Israel), a GLP certified contract research organization (CRO). 

 

Michal also worked at Gsap, a consulting company for healthcare companies.