Hong Chen，Vice President, Chengdu Easton Biopharmaceuticals Co., Ltd

Topic: Troubles with Visible Particles in Injection

 Speaker Bio

Dr. Chen is currently the Vice President of Easton Biopharmaceuticals and the President of the R&D Center. He has been honored the "Hundred/Thousand Talents Program" medical expert by both Hubei and Sichuan Province. He received his Ph.D. in analytical chemistry from Cleveland State University in 1996. He then spent two years in biomedical postdoctoral research at the Cleveland Clinic Foundation, the world's most famous cardiology clinic center. He has 25 years of working and management experience in Adolor, J&J, Teva and Nexgen Pharma in the United States and Yiling Pharma. He has served as Director of Analytical and Technical Services of Teva, the world's largest generics company, and R&D Director and Senior Director of Nexgen Pharma, USA，R&D Vice President of Yiling Pharma. Directly led and participated in the development of more than 30 new drugs and generics, including a Class 1 new drug (Entereg), 15 ANDA solid and liquid products approved by the US FDA and 3 products approved through Consistency evaluation by China CDE. He is responsible for the research and development of new, 505b2, generic drugs and ANDA registration of Easton Biopharmaceutical. Dr. Chen has extensive experience in team building, project management, GMP certification, establishment of R&D quality system and ANDA filings. He has published, lectured and presented more than 113 scientific papers in drug discovery and biomedical science.

Presentation Summary

Worries from Regulatory Agencies

Confusion in the injection industry

Uncertainty in the R&D process

Why it make my headache? 

What should we do?