TGN1412 and PMOA –Story of a monoclonal antibody that did the unexpected
Inside Out Quality
English - March 23, 2021 10:00 - 50 minutes - 34.5 MB - ★★★★★ - 6 ratingsScience quality assurance sdbio biotech medical devices Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
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In this episode, Diane and I are joined by Husain Attarwala, Head of Pharmacometrics and Clinical Pharmacology at Moderna and author of a paper diving into the 2006 failed clinical trial of TGN1412. We discuss how things went wrong, and what to consider when planning clinical trials to help keep study participants safe.
Kelly Creighton, VP for Regulatory and Strategic Development at Clinipace also joins us to discuss the importance of understanding the Primary Mechanism of Action (PMOA) of biologics and FDA expectations.