Dr. Derek Hei is Chief Technology Officer at Kenai Therapeutics. He has over 30 years of experience developing cell and gene therapies with expertise in process/assay development, manufacturing and Quality Control testing in compliance with current Good Manufacturing Practices (cGMP), and regulatory affairs. Following his Ph.D., Dr. Hei worked at Genentech and Cerus Corp. before taking a position at the University of Wisconsin to lead the development of Waisman Biomanufacturing, a CDMO that specializes in early-stage development of cell and gene therapies. At Waisman, Dr. Hei led several NIH-funded initiatives including the first National Stem Cell Bank, with a goal of developing standards for production and testing of human embryonic stem cells (hESCs). That program led to the development of some of the first hESC and induced pluripotent stem cell (iPSC) lines to be successfully advanced into human clinical trials.  

Dr. Hei followed the rapidly evolving iPSC field back into industry with roles including Vice President of Clinical Manufacture, Quality and Regulatory at Fujifilm CDI, Chief of Manufacturing and Technical Operations at BlueRock Therapeutics, Senior Vice President of Cell and Gene Therapy Pre-Clinical and Clinical Manufacturing at Vertex Pharmaceuticals, and most recently, Chief Technology Officer for Clade Therapeutics. In these roles, he has developed the CMC strategy for several cell therapies derived from iPSC lines including gene edited iPSCs. He has been responsible for building CMC teams and working with the teams to execute process/analytical method development plans and transition programs from R&D into cGMP-compliant manufacturing and QC testing to support human clinical trials.

Dr. Hei holds a Bachelor of Science in chemical engineering from the University of Wisconsin-Madison, and a Doctor of Philosophy in biochemical engineering from the University of California, Berkeley.