
Marc Better, PhD
Cell Therapy and Biologics Process Development Expert
Career Highlights
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Senior Consultant, Pharmefex
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Cell therapy and biologics CMC consulting
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More than 20 years of experience in cell therapy and biologics CMC; upstream, downstream, analytical and drug product process development; non-GMP and GMP manufacturing; Quality by Design; commercial manufacturing support; technology transfer, contract manufacturing of cell therapy products and recombinant proteins; and regulatory interactions
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Senior Vice President, Product Science, Kite Pharmaceuticals
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Led a group of 85 scientists and engineers responsible for process development, technology transfer, manufacturing support and overall CMC activities for autologous and allogeneic engineered T cell therapeutics
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Oversaw CMC operation teams, analytical development, process characterization and process validation activities
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Delivered four engineered T cell products to US IND
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Completed CMC activities leading to the successful US licensure of Yescarta, a first in class anti-CD19 CAR T cell therapy in October 2017
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Extensive regulatory interactions worldwide, including US, EU, Canada, China and Japan
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Executive Director, Process Science, Boehringer Ingelheim
Pharmaceuticals Inc. -
Executive Director, Process Development, Amgen
Education
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BS, Microbiology: Michigan State University
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PhD, Biochemistry: Brandeis University