April 28 - Day 1 - CT (China Time, GMT+08:00)
Details of the clinical development and regulatory communication for IM96, a novel GCC CAR-T product in Clinical Phase 1. We will highlight the molecule design guided by clinical unmet needs and its demonstrated advantages, including a ≥50% ORR and well-controlled costs supported by an integrated manufacturing platform.
- Ting He - Founder and CEO, Imunopharm Technology Co., Ltd.
- The definition of change in CGT products
- The trigger of post-approval change in cell therapy products
- The Category of cell therapy products’ change
- The major CMC change of cell therapy products – Innovation consideration, Supply chain, quality & document system, manufacture and release, continue monitoring, maintenance and re-change of the change
- Wenshi Wang - SVP Tech & Ops, FosunKairos
Asian CGT developers expanding into EU/U.S. face complex regulatory, manufacturing, and logistics challenges. The right European CDMO partner can de-risk global development and execution by:
- Bridging EU/FDA regulatory requirements
- Access to GMP-grade donor material
- Process/analytical development
- Scaling GMP manufacturing from clinical to commercial supply
- Validated transport solutions (Europe to China < 36 hours)
- Armin Ehninger - Managing Director Chief Scientific & Strategic Officer, Cellex Cell Professionals GmbH
- Cost drivers in gene therapy development and manufacturing
- Scrap & COGs reduction strategies in gene therapy development and manufacturing
- Beyond approvals; building sustainability and resilience in gene therapy manufacturing
- Anthony Chikere - Director, Vector Process Development, Sangamo Therapeutics, Inc.
In recent years, while innovative therapies using cells have attracted attention, high drug prices have become a dilemma. One of the keys to the advancement of cell therapy products is manufacturing automation through robotics and AI. In this presentation, I will explore global trends in research and development, introduce specific examples of strengthening manufacturing processes, reducing costs, and data driven process optimization, and demonstrate the possibilities for innovation.
- Hideto Yamaguchi - President & CEO, Cellafa Bioscience Inc.