REGULATORY PATHWAYS TO COMMERCIALIZATION: WHERE DO WE STAND ON THIS JOURNEY?
1:30pm – 2:30pm CET (Europe) / 7:30am – 8:30am ET (USA)
This session brings together leading regulators from around the world to discuss the ability of regulatory frameworks to deliver advanced therapies to patients globally. It will consider whether existing tools, such as facilitated regulatory pathways, are living up to their aspirations and are capable of meeting the demands of stakeholders to address unmet medical need in this rapidly evolving sector. In particular, considerations around the development of advanced therapies for slow progressing, chronic conditions and orphan conditions, including the optimization of traditional and novel endpoints and the role of early diagnosis, will also be discussed.
John Way, Ph.D., VP, International Regulatory Sciences, Biogen
Ana Hidalgo-Simon, M.D., Ph.D., Head of Advanced Therapies, European Medicines Agency (EMA)
Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA)
Yoshiaki Maruyama, Ph.D., Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA)
Christian Schneider, M.D., Interim Chief Scientific Officer, Medicines and Healthcare Products Regulatory Agency (MHRA)