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Bruce Kerwin, Ph.D.

Bruce Kerwin, Ph.D.

Prin. Consultant

Dr. Kerwin has 30 years of leadership experience in industry developing drug products for biologics. He is a recognized expert in protein formulation and drug product design. During his career he has developed formulations and designed development strategies for multiple products from pre-clinical to commercial including Kineret, Aranesp and Imlygic. Bruce was formerly a Scientific Director at Amgen, VP of Drug Product Design at Just-Evotec Biologics and SVP of Process and Product Development at Umoja. 


He has led numerous drug product development teams and scientific research teams developing novel solutions to formulation problems such as high viscosity, high concentration, co-formulation of proteins, protein aggregation and formulation of viruses for subcutaneous, intravenous, intrathecal intravitreal and device delivery technologies. Work on large and small volume parenteral formulations included recombinant hemoglobin, cytokines, monoclonal antibodies, antibody drug conjugates, PEGylated proteins, glycosylated and non-glycosylated proteins, oncolytic viruses and lentivirus. As an integral member of multiple product teams he has also written drug product sections for multiple regulatory documents, participated in writing FDA pre-meeting documents and in-person FDA meetings. 


Bruce received his Ph.D. at the University of California at Davis followed by a Postdoctoral Fellowship at Washington State University. He has over 60 scientific publications, 14 patents and multiple invited lectures at international scientific conferences. He is currently a Scientific Advisor for Coriolis Pharma and a member of the editorial advisory board for the Journal of Pharmaceutical Science.

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