The speakers will dive into various case studies and look at the impacts of early-stage QT assessment given positive and negative results as well as the context of the drug development project.
TORONTO (PRWEB)
March 09, 2023
Cardiac safety continues to be the #1 reason for trial failure amongst drug candidates as drug-induced QT interval prolongation can lead to sudden cardiac death. However, addressing this risk through a full Thorough QT (TQT) study in later phases is costly and leaves sponsors vulnerable to black box warnings and outright rejection in the 11th hour. Early phase QT assessment amongst healthy volunteers is available and can minimize QT risk at a fraction of the cost. However, securing TQT waivers with this approach historically required supratherapeutic doses that were sometimes not achievable due to limited tolerability.
In this webinar, the featured speakers will describe how the new ICH S7B/E14 revisions open up new opportunities for drug developers and discuss on-going trends in First-In-Human ECG studies. The speakers will dive into various case studies and look at the impacts of early-stage QT assessment given positive and negative results as well as the context of the drug development project. Additional consideration will be given to best practices with non-clinical hERG assays and in vivo QT studies as well as Section 6.1 of the guidance, covering drugs such as oncologics.
Join this webinar to learn about new developments that enable easier TQT waivers from early phase heathy volunteer and oncology studies. Sign up early to get your question in the queue for the experts!
Join experts from Clario, Borje Darpo, MD, PhD, Chief Scientific Advisor, Cardiac Safety; and Robert Kleiman, MD, Vice President, Cardiology & Chief Medical Officer, for the live webinar on Thursday, March 30, 2023, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit New Options for TQT Waivers from First-in-Human and Oncology Phase I Studies.
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