Explore the Agenda
9:00 am Registration & Networking
Morning Workshop
10:00 am Spotlight on In Vivo Development in Asia to Inform Global Clinical Development Strategies
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
12:30 pm Lunch Break
Afternoon Workshop
1:30 pm Enabling Extrahepatic Delivery to Increase the Range of Treatable Diseases
As in vivo therapies expand beyond the liver, enabling extrahepatic delivery is essential to unlock new indications. This workshop explores strategies to reach CNS, bone marrow, lung, kidney and immune cells using approaches highlighted across the field.
This workshop will:
- Compare extrahepatic delivery strategies including localized routes, passive targeting, antibody- or bispecific mediated attachment, and next-generation LNP/viral designs
- Outline how teams evaluate biodistribution, species differences and regulatory expectations for non-hepatic targeting
- Provide a framework to select and validate delivery approaches that broaden the treatable disease landscape
- Share practical considerations to reduce CMC burden while achieving precise extrahepatic tropism