Dr. Hien-Anh Bruno is an Associate Director in the Certara’s Chemistry, Manufacturing & Controls (CMC) group

Hien-Anh (HA) focuses on technical operations for novel therapeutics discovery and development, with an emphasis on clinical bioanalytical assays and CMC manufacturing processes across all therapeutic modalities (complex biologics, cell and gene therapies as well as small molecules).

HA works closely with toxicology, regulatory strategy and clinical pharmacology teams to ensure all aspects of CMC plus bioanalytical assays are compliant and ready for clinical trials and global regulatory submissions.

She has a track-record of building multiple teams/facilities, leading projects spanning from discovery, pre-clinical assessment to cGMP drug manufacturing, and has helped 40+ clients in developing and validating clinical PK/PD/ADA assays. Prior to joining Certara, she led the CMC team at Aceragen, managed the core R&D services at Exicure, assembled the tissue culture division at SAMDI Tech (a Charles River company), and led technical operations at Enzyme by Design Inc.

She obtained her PhD in Biochemistry at the University of Grenoble, her first postdoc training in System biology and Bioinformatics at the Institute Curie, and her second postdoc training in Structural Biology at the University of Illinois at Chicago.