Cécile Bauche

As in vivo cell and gene therapies moves into the clinic worldwide, diverse regulatory  pathways across Asia are shaping how quickly first patients are dosed. This workshop examines the role of Asia with a focus on China’s investigator-initiated trials and what  global sponsors can responsibly learn from them. 

This workshop will:

• Cover essential elements of study design, CMC planning, safety monitoring, ethics, and data quality
• Explain how to effectively bridge investigator-initiated trials into registrational pathways
• Provide clear decision criteria and practical guidance on when to leverage Asian clinical evidence
• Share collaboration models and a practical playbook for integrating Asian data into global development plans