Derek J. Hei, PhD
Position title: Senior Vice-President, Manufacturing, Quality & Regulatory, Blue Rock Therapeutics
BS 1988, Chemical Engineering, University of Wisconsin, Madison, WI
PhD 1993, Chemical Engineering, University of California, Berkeley, CA
Derek Hei is Senior Vice-President of Manufacturing, Quality & Regulatory at Blue Rock Therapeutics, headquartered in Cambridge, MA.
Previously, he was the Director of Waisman Biomanufacturing, which is designed to manufacture cell and gene therapeutics for early stage (Phase I and Phase II) human clinical trials according to the FDA’s cGMP guidelines. This is a state-of-the-art cleanroom facility located at the University of Wisconsin-Madison’s Waisman Center. Waisman Biomanufacturing is capable of providing development and manufacturing services for a wide range of biotherapeutics. In addition to facilities and equipment for producing plasmid DNA and viral vectors for gene therapy, Waisman Biomanufacturing has facilities for processing cell therapeutics including embryonic and neural stem cells, filling of parenteral therapeutics, and producing recombinant proteins. This range of capabilities allows Waisman Biomanufacturing to provide support to both academic and commercial groups that are involved in the development of complex, multi-component biotherapeutics such as engineered stem cells. His group partners with academic investigators, biotechnology companies, and NIH to move promising therapeutics through pre-clinical animal studies into early-stage clinical trials. Their expertise in the areas of manufacturing process development, analytical method development, and FDA regulatory requirements allows them to assist translational investigators in efficiently advancing their therapies into the clinic.
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