Charles Gentile

Consultant
Global Clinical Supply Chain Leader
Charles Gentile is formerly the Senior Director - US Site Head, Clinical Supplies – Scientific Core Platform for Sanofi US, Great Valley, PA. In this position, Charles managed all aspects of the project management, packaging, labeling, assembly and distribution of investigational products at the Sanofi US Clinical Supplies site. Charles has held a variety of leadership positions in the approximately 25 years of Clinical Supplies experience in the pharmaceutical industry and has been with Sanofi since 2008. Prior, Charles was with GlaxoSmithKline for 18 years. He earned a Bachelor’s degree in Organizational Management from Cabrini University. He is a member of ISPE and has served as the Co-Chair and Chair of the ISPE Investigational Products Community of Practice Steering Committee in 2017 and 2018 respectively and is currently a member of the steering committee. Charles can be contacted by email: cwgentile@verizon.net.

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The landscape of clinical trials has evolved significantly with the pandemic and interest in utilization of decentralized clinical trial (DCT) designs as a mitigation and the need for remote data collection. In response to this shift, the US Food and Drug Administration (US FDA) has released draft guidelines to try to provide clarity on the use of DCT models in clinical trials. While the...