Manufacturing Advisory Board

Gerhard Bauer
Gerhard Bauer is a Professor of Hematology/Oncology and the Director and Designer of the UC Davis Good Manufacturing Practice Facility. He has 25 years of experience in manufacturing first-in-human cellular therapy products. Prof. Bauer has been involved in the design and construction of six GMP cell manufacturing facilities, including the highly advanced UC Davis GMP facility launched in 2010. Prof. Bauer was recruited to UC Davis in 2006 from Washington University in St. Louis, where he directed the GMP facility he also designed. Prior to that, he developed the clinical-grade cell manufacturing and transduction procedures for stem cell gene therapy for children with ADA-deficient SCID and for stem cell gene therapy for HIV at Children’s Hospital Los Angeles, the pediatric department of USC. Prof. Bauer received his education in Laboratory Sciences and Medicine at the University of Vienna, Austria.

Mike Dey, PhD
Mike Dey, PhD, is Managing Director of Claidmhor Pharma Limited. He has more than 35 years of pharmaceutical development and manufacturing experience, including management of development, industrialization, and manufacturing operations for Ipsen, Aventis (now Sanofi), and Syntex (now Roche) at more than 10 sites that included developing peptide, protein, and small molecule-based products in oncology, endocrinology, hematology, cardiovascular, and neurological disease areas. At Ipsen, Dr. Dey led product development and industrialization teams in the U.S., France, Ireland, U.K., and Spain, as well as 10-year strategic plan development and implementation for endocrinology therapies. At Aventis, he led technical/industrialization activities for manufacturing sites in U.K., Ireland, Spain, and Italy, overseeing production of more than 30% of global sales and major product launches. During his professional career, Dr. Dey has led construction and regulatory approvals and has managed new manufacturing sites in Singapore, U.K., Ireland, France, and Spain for drug substances, drug products, and medical devices. He has managed more than 30 contract manufacturing partnerships involving major capital and technology investment that led to more than 25 NDA/BLA approvals, including nine biologics. Dr. Dey holds a BSc First Class Honours in Pharmacy and a PhD in Pharmaceutical Technology/Chemical Engineering from Robert Gordon’s Institute of Technology, Aberdeen, U.K.

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