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Steve D. Hughes, Ph.D.

Sr. Consultant


Dr. Hughes has over 21 years of experience in biopharmaceutical and cellular therapy product development, ranging across multiple disciplines of manufacturing, research and development.  From his most recent experience leading the process development team at Dendreon, he has extensive experience in development of cellular therapeutic products, and in supporting commercial phase production using risk assessment methodology and experimental models to evaluate potential process changes or improvements.  Dr. Hughes’ experience also includes pharmacology, toxicology and project management/leadership.  His pharma career began at Zymogenetics, where he started in early-stage research followed by a series of roles in pharmacology, toxicology and product development teams.  Dr. Hughes then began work at Dendreon in 2010, where he led a cellular therapy product development team and managed early-stage development projects.  He then took the role of leading the team responsible for support and innovation of the manufacturing process for Dendreon’s Autologous Cellular Immunotherapy product Provenge™, an activated cell therapy approved to treat metastatic prostate cancer. In this role, he directed a number of initiatives aimed at improving manufacturing process performance, including adaptation of closed system processing solutions, investigation and resolution of process yield trends, and continuous improvement initiatives such as streamlining process monitoring operations.  Dr. Hughes holds a Ph.D in Biochemistry from the University of Texas Southwestern Medical Center in Dallas, TX and was a Postdoctoral Fellow at Lawrence Berkeley National Laboratory Life Sciences Division and Human Genome Center in Berkeley, CA.

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