Ryan MacKenzie

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Merck
Senior Director of Global Regulatory Affairs–CMC
Ryan MacKenzie is Senior Director of Global Regulatory Affairs–CMC at Merck, where he is a team leader responsible for development and implementation of regulatory strategy for pipeline products spanning Phase 1 clinical studies through initial marketing applications. Ryan has over 25 years of pharmaceutical industry experience including analytical sciences and 19 years in global regulatory CMC at Merck and Janssen. Ryan previously led Merck’s COVID-19 small molecule therapeutic CMC team resulting in expedited global access including US EUA and he has now transitioned into the New Modalities Biologics space focused on antibody drug conjugates. Ryan holds a bachelor’s degree in chemistry from Pennsylvania State University.

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Figure 3: Industry develops a single global control strategy.
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Toward a Single Global Control Strategy: Industry Study

During the past decade, industry has experienced a proliferation of regulatory divergence regarding the interpretation and implementation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (and control strategies) across geographic regions. This article shares data that highlight instances where well-established ICH...