Where China's Top Domestic & Multinational Clinical Development Leaders Meet

This year, we will dive deeper and more specific into the topics that will drive innovative drug development from China for years to come. With so many moving targets in regulatory policy, clinical talent, role of CRO's, relationship between MNC's and domestics, we will aim this year's content squarely on strategies to keep you and your team at forefront of China clinical development. 

 

1.    Develop Your Strategy to Succeed in the Fast-Changing Relationship Between Domestic Biotechs and MNC Pharma in China

  • Compete or Collaborate: What’s the best way forward for MNC’s and domestic companies to succeed in China? 
  • If MNC’s successfully bring their first-in-class therapies to China and price aggressively, how will domestic biotechs survive?
  • Is “me-too / me-better” still a viable strategy for domestic companies?
  • Talent War: How is the fierce competition for clinical development talent impacting the overall drug development industry in China?

 

2.    Navigate China’s Regulatory Reform: The Industry Dynamics Have Changed Much Faster Than Expected

  • Learn from case studies presented by companies who were granted accelerated review/approval: which regulatory path should you select for your new drug registration?
  • Registering imported drugs: what are the key takeaways from companies that have successfully leveraged foreign data for approval in China this year? 
  • Perspectives from China’s top principal investigators: how do they judge the implementation of the new policy and where do they see the biggest room for improvement?

 

3.    Apply the the Latest Concepts in Innovative Trial Designs & Statistical Methods to Bend the Time/Cost Curve of New Drug Research

  • Take part in the special interactive 2-hour session featuring Medical + Statistics management teams from China’s top biotechs as they openly discuss the critical need to work together for their company to succeed
  • Join the in-depth 3-hour workshop led by some of China’s top statisticians and learn how to apply the latest concepts in Adaptive Designs, BLRM use in dose-finding, two-stage design in confirmatory trials and much more.
  • See what the future of innovative trial design holds: Virtual and Synthetic-Arm Trials

 

4.    ICH Year One: Analysis of China's Implementation

  • Since ICH entry, what changes have been successfully implemented and where do current gaps still exist?
  • What has the impact of China's ICH entry been on the CFDA's thought process?
  • Latest updates to ICH E17 MRCT guidelines and rules
  • The impact on safety reporting: what changes have we seen since China’s ICH entry? 

 

5.    Hot Topics Coverage on Cell Therapy Clinical Development in China

  • What are the critical factors to consider when designing and implementing cell therapy trials?
  • What unique advantages does China have compared to the rest of the world for cell-therapy R&D?
  • How do we overcome challenges with patient recruitment due to high number of cell therapy trials in China?
  • How to develop your patient safety strategy for cell therapy clinical trials?