Lorella Di Donato

Lorella received her PhD in Biochemistry from the University of Montréal and is a well-respected executive in the CRO industry. Her scientific expertise includes assay development and validation using different types of platforms (mass spectrometry, immunoassays, flow cytometry, ELISpot, and others) for the analysis of biomarkers, as well as drug products. Dr. Di Donato has validated over 200 assays and was instrumental in the deployment of these assays from exploratory to primary endpoints, combining the technical and scientific aspects, along with the regulatory requirements. Dr. Di Donato has been actively involved in regulatory audits throughout her twenty years in the CRO industry. She is also a regular contributor and presenter at the WRIB, co-authoring many of the white papers. In addition,, Dr. Di Donato has been a speaker at several international conferences on proteomics for biomarkers and drug product quantitation.

Since 2012, Dr. Di Donato has led the scientific operations team at a global level at Caprion Biosciences (North American and Europe). She oversees immune monitoring, proteomics, bioinformatics, and project management, supporting drug development programs. Prior to joining Caprion, Dr. Di Donato was Vice-President, Research and Development at Cirion BioPharma Research, responsible for technology transfer, method development and validation of biomarker, PK, and immunogenicity assays.