Kenai Therapeutics, United States
Derek Hei currently serves as the Chief of Manufacturing and Technical Operations for BlueRock Therapeutics. He has over twenty five years of experience developing breakthrough cell and gene therapies including expertise in cGMP manufacturing, QC testing and regulatory compliance. At BlueRock, Derek currently oversees the clinical manufacturing function including developing and producing BlueRock’s iPSC platform, maintaining its state-of-the-art cleanroom facility and cGMP Quality System, and leading the CMC regulatory efforts. Dr. Hei previously served as VP of Clinical Manufacture, Quality and Regulatory at Cellular Dynamics International in addition to prior positions at Waisman Biomanufacturing, Cerus Corp and Genentech. Dr. Hei obtained his B.S. in chemical engineering from the University of Wisconsin-Madison, and his Ph.D. in biochemical engineering from the University of California, Berkeley.
BEST PRACTICES FOR THE DEVELOPMENT OF PSC-DERIVED CELLULAR THERAPIES
Thursday, July 11, 2024
8:15 AM – 9:45 AM CEST
INSIGHTS FROM REGULATORS: LESSONS LEARNED FROM THE ISSCR’S REGULATORY LIAISON MEETINGS
Saturday, July 13, 2024
8:15 AM – 9:45 AM CEST