Memo
This conference will explore how regulatory sciences can be used to accelerate the development and availability of biologics and vaccines and to enable manufacturing innovation. It will be unique with its focus on the science driving regulatory advances – analytical characterization, process design, materials sciences, real time release, quality-by-design and personalized medicine – and in bringing together participants from each of the four major groups – regulators, academics, non-government organizations and industrialists — involved in regulatory innovation for intimate discussions on these topics in a format that maximizes the time for discussion and interaction.
It will bring together academic scientists/engineers who are focused on manufacturing innovation such as continuous biomanufacturing or in-field/at patient bedside production/release of biologics, industrial scientists/engineers interested in process innovation (real-time release, process intensification, multiparameter process and product characterization), scientist/engineers at not-for-profit organizations dedicated to increasing access via process/product innovation (process optimization, novel delivery, thermal stability) and scientists/engineers at the National Health Authorities focused on applying regulatory science to enable product and process innovation.
