Thomas O’Connor, PhD

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Deputy Director
Thomas O’Connor, PhD, is Deputy Director of the Office of Testing and Research in the Office of Pharmaceutical Quality and is Vice Chair of CDER’s Emerging Technology Team (ETT). His responsibilities include managing research and testing projects that answer and anticipate pharmaceutical quality-related regulatory challenges through scientific approaches. Tom is a co-author of a number of papers on advanced manufacturing such as CM, 3D printing, and the use of modeling and simulation for quality assurance. Through the ETT he has contributed to the assessment of several regulatory applications utilizing novel technologies. Tom earned a BS in chemical engineering from the Cooper Union and a PhD in chemical engineering from Princeton University.

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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing
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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization.