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Confirmed title: Challenge and strategy for successful ADC external manufacture
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19 June: 14:30 - 15:00
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Kyle Blair, Global Category Manager, Biologics, AstraZeneca
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ABSTRACT
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The manufacture of Antibody-Drug Conjugates presents unique challenges for outsourcing. Concerns around high containment, multiple supply chain nodes, limited pool of commercial suppliers, and uncertainties around early stage material demand all need to be addressed. Kyle will present one approach for using those challenges to inform the CMO selection process that has been successfully employed by AstraZeneca. He will also identify key elements of partnership with the selected CMO that can enhance chances for success.
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BIOGRAPHY
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Kyle began his career in Discovery Chemistry at Pfizer working on all the major classes of antibacterial agents. During his time at Pfizer Kyle earned a Master’s degree in Organic Chemistry from the University of Connecticut. Beginning in 2002, Kyle joined the outsourcing arm of Pharmaceutical Development at Pfizer. After several years managing FTE collaborations in support of Discovery programs, he joined the late stage development group to manage contract manufacturing relationships in support of key late stage assets, notably Xeljanz and Xalkori. Since 2011 Kyle has been part of the AstraZeneca Operations Procurement organization supporting external manufacture of biologics drug substance and drug product. In addition to Antibody-Drug Conjugates, Kyle currently supports external partnerships covering a broad spectrum of biopharmaceuticals including oncolytic virus, plasmid DNA, messenger RNA, monoclonal antibodies and fragments, microbial expression products, and peptides. |
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COMPANY PROFILE
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AstraZeneca
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