Where China's Top Domestic & Multinational Clinical Development Leaders Meet
1. How Should MNC’s and Domestic BioPharma Companies Respond in this New Era of China Development?
- Where are the current gaps in China’s clinical capability and how can we bridge them?
- What impact on trial costs will result from the high competition for resources (sites, CRO’s, talent) to come?
- How will MNC’s leverage CFDA proposals 52-55 to speed up registration in China?
- What’s the best model for MNC’s and domestic biopharma to collaborate?
- The impact of new policy on MRCT and NDA strategies for China and East Asia
2. CAR-T & PD-1/PD-L1 Spotlight: Immuno-Oncology Trial Design & Development Strategies for China
- What are the critical factors to consider when designing and implementing CAR-T trials?
- Achievements & challenges of CAR-T in clinical development for hematology cancers and solid tumors
- Why are we running so many PD-1/PD-L1 trials in China and how should you position your pipeline strategically?
- Perspectives from Chinese patient advocacy groups on IO clinical trials
- Analysis of global immuno-oncology clinical trials: what have we learned?
3. Interviews with Top Chinese Principal Investigators and Patients
- Candid insights from top Chinese investigator and patients
- Are PI’s excited or concerned about the pending policy changes?
- How can we expand the pool of high-quality investigators and prepare China to be more clinically capable?
- How can industry and sites collaborate better with patients and patient advocacy groups?
4. New Horizons for Early Development in China
- Key considerations for designing FIH studies, site selection and analyzing FIH study data
- MNC’s and global Phase I studies in China: how might it work?
- What are the key regulatory differences when conducting FIH studies in the US vs. China?
- What are the pro’s and con’s of conducting FIH studies in Australia?
5. Learn Best Practices for Successful Global NDA/BLA Filing and Final Approval
- How to design one protocol to fit global needs
- How to prepare a comprehensive clinical submission dossier
- How to navigate FDA and EU review and approval process
- How to manage all of the many different moving pieces (project management role on timeline and resource management)