Myleen Leoncavallo, M.S., RAC——Senior Vice President of Regulatory Affairs and Quality Assurance

Mrs. Myleen Leoncavallo has over 25 years of experience in drug development and regulatory affairs (with 10 years in rare disease), including the filing of 4 New Drug Applications, 2 Biologics License Applications, 5 Marketing Authorization Applications, 2 New Drug Submissions, 18 Investigational New Drug Applications, and 14 Clinical Trial Applications. 

Prior to HighTide, she served as Vice President, Head of Global Regulatory Affairs at Mirum Pharmaceuticals, Inc., where she established their global regulatory function and played a key role in securing approval of LIVMARLI® for the treatment of cholestatic pruritus in Alagille syndrome, and also provided regulatory strategic leadership for the global development of maralixibat for progressive familial intrahepatic cholestasis and biliary atresia. Mrs. Leoncavallo also contributed to Mirum’s earlier stage program, volixibat, in primary sclerosing cholangitis, primary biliary cholangitis, and intrahepatic cholestasis of pregnancy.   

Mrs. Leoncavallo holds Master of Science degrees in both Regulatory Science and Pharmaceutical Chemistry from the University of Southern California in Los Angeles, and is Regulatory Affairs Certified (RAC) in both the U.S. and EU.


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