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
Program Manager, Accellient Partners
Dr. Xiang Yang Yu has been an independent consultant as Director of Preclinical Development at Acurx Pharmaceuticals since June 2018. She has been a Program Manager at Accellient Partners with responsibilities for API and drug product CMC manufacture as well as for regulatory writing/filings including FDA IND and European IMPD submissions/amendments/annual reports. She has also been involved in managing CMC in multiple clinical trials from Phase I to Phase III in multiple therapeutic areas since 2014. Prior to that, she was a principal investigator at Ironwood Pharmaceuticals where she was involved in drug discovery and development programs in multiple therapeutic areas as well as efficiently and strategically managed external drug discovery and development collaborations in the US, Europe and Asia. Prior to joining Ironwood, Dr. Yu was Director of Medicinal Chemistry at Epix Pharmaceuticals leading successful drug discovery programs. She was the chemistry project leader for S1P program licensed to Amgen for highly potent, selective and orally active agents for autoimmune diseases leading to $20 million upfront payment and $307 million milestone payment in a record 9 months. Dr. Yu was also a chemistry project leader for a GSK collaborative discovery program which resulted in $5.5 million upfront payment in 7 months. Before joining Epix, she led multiple anti-infectious programs at Activbiotics and Cubist Pharmaceuticals. She obtained her MS and Ph.D. degree in Organic Chemistry from Florida State University. She received her undergraduate degree from East China University of Science & Technology in Shanghai. Dr. Yu is a Board Director and President of the Chinese American BioMedical Association (CABA) since 2014 (a 501(C)(3) not-for-profit professional organization. She was the President of CABA - (2013-2014). She is currently a Co-chair in MassBio Forum at MassBio and a BayHelix member.