Speakers

Dr. Diane McCarthy is Vice President, Global Biologics at USP, where she leads the development of science-based standards and tools to address critical challenges across the biotechnology industry and ensure the quality of biologic medicines worldwide. She oversees global programs spanning monoclonal antibodies, cell and gene therapies, vaccines, oligonucleotides, peptides and biomarkers. She also directs the development and lifecycle management of documentary and physical reference standards, ensuring their scientific rigor and global applicability. Prior to USP, she held leadership roles in CROs specializing in mass spectrometry–based characterization of biologics, host cell proteins, and biomarkers. Her leadership combines deep technical expertise with a strategic focus on advancing standards that enable innovation while protecting patient safety.