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
Executive Chairman of Fountain Medical Development Ltd.
Dr. Dan Zhang is the Executive Chairman of Fountain Medical Development Ltd, a clinical CRO with 1700 employees operating in China, Hong Kong, Taiwan, South Korea, Japan, UK, India, Philippines, Armenia & USA. Dr. Zhang was the Head of Clinical Development and was the Head of Safety Assessment at Sigma-Tau Research Inc-leading Italian Pharmaceutical Company, He was the vice president at the Quintiles Transnational Corp., and Chairman of Quintiles Medical Development (Shanghai) Company Ltd., Dr. Zhang is a member of grant review committee for National Drug Development Fund of China, and is also a consultant for the China Food and Drug Administration (CFDA). He is a member of ICH E19 Expert Working Group. He is also chairing the committee of Pharmaceutical R&D, China Pharmaceutical Industry Research and Development Association. Dr. Zhang is also a senior consultant for the Chinese Academy of Medical Sciences and Peking Union Medical College. He was a member of the Overseas Expert Committee on New Drug R&D for the Ministry of Science and Technology of China. Dr. Zhang was the former board of directors for the Sino-American Pharmaceutical Association (SAPA) and was the former president of Chinese Biopharmaceutical Association-USA (CBA). Dr. Zhang is chairing the government relationship committee of Bayhelix-an organization hosting senior executives from life-science organizations in USA and China. Dr. Zhang received his pre-med training from Peking University and received M.D. from Peking Union Medical College. He then went to the Harvard School of Public Health and received MPH in health policy and management. Then he went to the Wharton Business School of the University of Pennsylvania, where he obtained his master’s degree in healthcare management in 1998