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)