BlueRock Therapeutics today announced the appointment of Derek Hei, Ph.D., as senior vice president, manufacturing, quality and regulatory.
"We are thrilled to have Derek join our team. He is a strategic leader with extensive experience in cell and gene therapy manufacturing and deep expertise in the unique quality and regulatory aspects of iPSC-derived cell therapies," said Emile Nuwaysir, Ph.D., chief executive officer of BlueRock Therapeutics. "He will play an instrumental role in the development and manufacture of our off-the-shelf therapies designed to reverse degenerative diseases like heart failure and Parkinson's."
Dr. Hei brings to BlueRock over twenty years of experience developing breakthrough cell and gene therapies from research through clinical trials. He has expertise in current Good Manufacturing Practices (cGMP) compliance, manufacturing, quality control, quality assurance, and regulatory compliance. Over the course of his career he has overseen the manufacture of cells, DNA, RNA, and antibodies for clinical use, and for release in numerous global jurisdications. At BlueRock, he will be responsible for the strategic planning and management of the company's manufacturing, quality, and regulatory functions, including its induced pluripotent stem cell platform, cellular differentiation programs, state-of-the-art cGMP cleanroom facilities, and lead the regulatory efforts for submitting an investigational new drug application.
Prior to joining BlueRock, Dr. Hei served as vice president of clinical manufacture, quality and regulatory at Cellular Dynamics International, where he oversaw the development and of its cell therapy products. Dr. Hei also serves as an adjunct professor, master in biotechnology program at UW-Madison where he instructs on aspects of biotherapeutic development including process development, scale-up, analytical methods development and key elements of Chemistry, Manufacturing and Control. Previously, Dr. Hei held various roles at Waisman Biomanufacturing, Cerus Corp and Genentech. Dr. Hei earned his Ph.D. in biochemical engineering from the University of California, Berkeley and his bachelor of science in chemical engineering from the University of Wisconsin-Madison.
About BlueRock Therapeutics
Driven by a vision to liberate patients from the burden of degenerative disease, BlueRock Therapeutics is ushering in a new era of cell-based medicine that repairs the body when it cannot repair itself. Founded in 2016 through one of the largest Series A financings in biotech history, BlueRock and its team of preeminent scientists are pioneering cell therapies that replace dead, damaged or dysfunctional cells to restore critical natural functions in the body. Using an approach that can be applied to multiple diseases with great unmet need, BlueRock is initially targeting severe brain and heart conditions, with the goal of altering the course of disease and drastically improving quality of life. BlueRock's culture is defined by scientific innovation, highest ethical standards and an urgency to bring transformative treatments to all who would benefit. For more information, visit www.bluerocktx.com.