Phacilitate Leaders Forum

Speakers

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Derek Hei

Derek Hei

Senior VP, Manufacturing, Quality & Regulatory, BlueRock Therapeutics

Derek Hei brings to BlueRock over twenty five years of experience developing breakthrough cell and gene therapies from research through clinical trials. He has distinct expertise in current Good Manufacturing Practices (cGMP) compliance, manufacturing, quality control testing and regulatory compliance for biologics including cell and gene therapies. At BlueRock, Derek currently oversees the entire clinical manufacturing function, which includes developing and producing BlueRock’s induced pluripotent stem cell platform, maintaining its state-of-the-art cleanroom facility and cGMP Quality System, and leading the CMC regulatory efforts for submitting investigational new drug applications. Dr. Hei previously served as vice president of clinical manufacture, quality and regulatory at Cellular Dynamics International, where he oversaw the development and production of its cell therapy products. Prior, Dr. Hei served at Waisman Biomanufacturing, Cerus Corp and Genentech. Dr. Hei obtained his bachelor of science in chemical engineering from the University of Wisconsin-Madison, and his Ph.D. in biochemical engineering from the University of California, Berkeley.

Sessions
Testimonials
  • Real thinking forward combining experts in the field from manufacturing, regulatory and value vision” – “great network with strong experience and sharing risks & opportunities
    Jean-Philippe Combal
    GenSight Biologics
  • The conference consistently proves to be a great forum for networking with industry leaders in the development of cellular and gene therapies as well as vendors for important technologies and services.
    Michael Covington
    Juno Therapeutics, Inc
  • It was a very interesting event as all participants, including speakers were ready to exchange, even on the most challenging subjects such as reimbursement, GMP guidance
    Bertrand Alexandre
    Celyad
  • Phacilitate EU delivered it's promise and more, the topics discussed were highly relevant, with very good and professional speakers and panelists. You will see me next year in Berlin.
    Dr Ohad Karnieli
    Karnieli Ltd