EPISODE · Dec 30, 2022 · 40 MIN
The Role of RWD in the Development of Remdesivir
from PharmaTalkRadio · host Conference Forum
In this session from DPHARM 2021, Gilead shares how they designed, developed and obtained Emergency Use Authorization and Full Approval for Remdesivir for the treatment of COVID-19 in record time. Key topics: How they built new capabilities at an extremely accelerated pace to design and execute the remdesivir trialsThe role of Real World Data (RWD) in remdesivir trials to understand the natural history of the disease, to inform study design and conduct, and support real world effectivenessManaging compassionate use programs and communicating with regulators at the peak of the global pandemicLessons learned and the impact on other therapeutic areas Speakers: Matthew Bryant, MBA, Head of Technology & Innovation Global Development and Clinical Operations, Gilead SciencesAnand Chokkalingam, PhD, Senior Director, Clinical Research, Gilead SciencesHassan Kadim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS
What this episode covers
In this session from DPHARM 2021, Gilead shares how they designed, developed and obtained Emergency Use Authorization and Full Approval for Remdesivir for the treatment of COVID-19 in record time. Key topics: How they built new capabilities at an extremely accelerated pace to design and execute the remdesivir trialsThe role of Real World Data (RWD) in remdesivir trials to understand the natural history of the disease, to inform study design and conduct, and support real world effectivenessManaging compassionate use programs and communicating with regulators at the peak of the global pandemicLessons learned and the impact on other therapeutic areas Speakers: Matthew Bryant, MBA, Head of Technology & Innovation Global Development and Clinical Operations, Gilead SciencesAnand Chokkalingam, PhD, Senior Director, Clinical Research, Gilead SciencesHassan Kadim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS
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The Role of RWD in the Development of Remdesivir
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