Should China Be Considered For Clinical Trials?

June 18, 2019 8:00 AM - 10:00 AM

MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139

Add to Calendar 6/18/2019 8:00:00 AM 6/18/2019 10:00:00 AM Should China Be Considered For Clinical Trials?

Offshoring of clinical trials can provide many benefits to pharma companies interested in reducing preapproval expenditures. However, many factors such as national infrastructure, patient pool, quality of data, and clinical expertise must be considered before selecting a country outside the US for each particular trial. China is making progress in attracting clinical trials due to its faster setup times, lower cost and improved quality data. Recent regulatory reforms of the clinical trial process have shortened the timeline to approval and have led to increased investment in China. Offshoring clinical trials to China can be an effective strategy to reduce cost and cycle time of drug development. China also has significant market potential and strong research capacity that can provide long term benefits to pharmaceutical and biotech companies. We will discuss the opportunity but also the challenges and how to minimize the associated risks.

Key questions our panel will address:

  • What are the main drivers for outsourcing clinical trials in China?
  • What is clinical trial process in China?
  • What are the strategies to control clinical development cost in China?
  • What are some of the significant changes in clinical trial occurring in China?
  • How has the timeline to get a trial approved in China been shortened so dramatically?
  • What will these changes mean for pharma companies hoping to conduct trials there?
  • What are challenges for outsourcing clinical trial to China and signs of improvement?

 MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139
Senior Medical Director, Takeda Oncology R&D
Dr. Pingkuan Zhang obtained her medical degree at Fudan University, Shanghai, China and was a licensed physician before joining industry in 2003. She worked for Sanofi, AstraZeneca and GSK in medical and R&D roles in China with increasing responsibility before moving to US as medical director for global pivotal studies at GSK in 2014. She designed and delivered life cycle management studies for the China and Asian regional unmet medical needs, and led the delivery of global pivotal studies. She successfully achieved line extension of global compounds in China, as well as new drug registration in US and Europe. She is currently Senior Medical Director, working for Takeda Oncology R&D, based in Boston.