[ May 10 (Thu) ]
Regulatory Strategy for Cell & Gene Therapy


This session will cover the latest trends and issues on regulation strategy on cell & gene therapeutics expected to be the next key technology as Big-data and precision medicine getting tremendous attention from the world. It introduces the current status of cell & gene therapeutics in U.S. and EU market and the practices on safety approval of clinical trials.


Session Chair Antonio Lee , Global Head, Business Development, MEDIPOST
Time Session Title
13 : 30 ~ 14 : 20 FDA’s Perspectives On CAR-T Manufacturing and Testing
GUANG GAO, Principle Consultant, Axteria Biomed Consulting Inc.
14 : 20 ~ 15 : 00 Successful Cell & Gene Therapy Regulatory Strategy in Europe
Mark Wood, Head of Data Services, Crown CRO
15 : 00 ~ 15 : 40 Considerations for Biosafety Testing of Cell and Gene Therapies
Richard Adair, Virology Manager, SGS Vitrology
15 : 40 ~ 16 : 00 Manufacturing for Chimeric Antigen Receptor (CAR) T-Cell and Gene Therapies
Philip Ridley-Smith , Sales & Marketing Director , Marketing/Sales, Cobra biologics