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David Wylie, Ph.D.

Principal Scientist, Biologics Analytical Sciences at Merck and Co.


A protein chemist by training, David Wylie has been involved in the purification development and analysis of over 25 novel and biosimilar drug candidates ranging in size from peptides to large multi-domain fusion proteins. He was instrumental overseeing the design, execution, analysis, and reporting the analytical similarity studies incorporated in the successful filing of Lusduna, a biosimilar to Lantus insulin glargine. Through his direct participation with biosimilar drug development and work with partners of Merck, he has gained firsthand knowledge of EU and US agency expectations for multiple biosimilar drugs since 2012. David received his PhD from Duke University. Unfortunately, his stay there did not coincide with a NCAA basketball championship.

Agenda Sessions