Marion Gruber is the Vice President for Public Health and Regulatory Science at the International AIDS Vaccine Initiative (IAVI). In this role she is leading the development and execution of IAVI’s public health and regulatory science efforts to advance IAVI’s product development programs in order to facilitate global access to preventive and therapeutic products critical for global public health. Prior to joining IAVI, from 1992 to 2021, she served as public health official at the US FDA where she held various research, regulatory and policy positions most recently serving as the Director, Office of Vaccines Research and Review (OVRR) ( 2011 to 2021). In that role she was responsible for the review, planning, development and administration of OVRR’s national and international programs directing a multi-disciplinary team engaged in vaccine and related biological product development, regulation and licensure. Other key responsibilities included collaboration with top level agency officials, industry representatives, foreign government representatives, other national regulatory authorities as well as global organizations such as WHO and CEPI to advice on regulatory policy, programs and licensure strategies for preventive vaccines to facilitate access of these products critical to global public health. Marion Gruber received her PhD degree in Microbiology from the Christian Albrecht University, Kiel, Germany and a MS in Biology from the University of Ulm, Germany .
· Defining Immunobridging – Use cases in outbreak scenarios and population expansion.
· Assay Development & Standardization – Challenges in T-cell vs. antibody assays
· Data Integration & AI Tools – Improving comparability and accessibility.
· Case Studies – MPOX, Nipah, MERS, Chikungunya.
· Academic vs. Operational Perspectives – Translating research into scalable solutions.