Date：23 July (Friday)
Time: 10:40 – 12:10 (GMT+8)
Dr. Wei-Kuang Chi, Vice President Since November 20, 2019 of the Development Center for Biotechnology (DCB), obtained his M.S in Engineering and Ph.D. in Chemical Engineering from the University of Pennsylvania, Philadelphia, USA. Dr. Chi has over 30 years of experience in biotechnology process development. He established DCB’s multi-product 500 L mammalian cell culture and 100 L microbial fermentation CGMP Biopharmaceutical Pilot Plant Facility (BPPF) and certified by Taiwan Department of Health (DOH) on December 2005 and received DMF with USA FDA on March 2006. The CGMP BPPF has been spun-off on 2013 into private sector to provide CDMO service on a broader scale. Dr. Chi’s new responsibilities focus on new drug R&D, international collaboration, novel bioengineering technology, CAR-T/iPSC development, application of deep learning/AI on drug discovery and /biomanufacturing process
CAR-T, a living drug, with fast growing global market of CAR-T cell therapy.
Five approved CAR-T therapies on hematological cancers since 2017 with 60-90% ORR.
Facing challenges on treating solid tumors using CAR-T with only 12.8% ORR.
Using biomedical data in CAR-T cell development for solid tumor treatment.
Globo-H chosen as a target antigen on solid tumors, and gastric cancer is the first indication.
Established a platform to systematically evaluate potential targets, cell lines and biomarkers for CAR-T cell therapies treating gastric cancers.
DoIT of MOEA has envisioned “CAR-T Therapy Development Scheme”, focused on solid tumors, CAR-T safety enhancement and manufacturing to lower COG, and covered CAR Design, Critical Material for CAR-T, CAR-T Manufacturing and Regulatory.