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IQ Induction WG: Focus on CYP3A4 mRNA InVitro Response Thresholds, Variability, & Clinical Relevance

December 6, 2018


This IQ Induction Working Group webinar will focus on the collation and review of a large set of in vitro and clinical CYP3A induction data aimed at understanding drug interaction interpretation and risk assessment as they relate to the current guidelines from Regulatory agencies.

This webinar will take the audience through the data that lead to key recommendations with respect to donor number, criteria for … Morecharacterizing positive and negative in vitro induction including the 2-fold cut-off, the value of negative controls, and finally indexing response to prototypical inducers. The intent of this webinar series is to promote discussion and collaboration among industry peers. This is a public forum so we encourage you to share this information with interested parties, you do not need to be an IQ member to register for these webinars.

Speaker Bios

Jane Kenny

Jane is an Associate Director and Principal Scientist in DMPK at Genentech. She received her PhD from the University of Liverpool (UK) and has over 15 years drug discovery and development experience. Her research interests include in vitro and computational ADME including evaluation and prediction of DDI. Jane led the data interpretation subgroup for the IQ induction working group.

Diane Ramsden

Diane is a Senior Scientist in early Development at Alnylam Pharmaceuticals. She received her BS from the University of Connecticut and is currently responsible for representing drug metabolism and pharmacokinetics (DMPK) on program teams and for designing mechanistic ADME studies. Prior to joining Alnylam she spent 16 years at Boehringer Ingelheim where she served as a DMPK project representative and hepatocyte lab head. She has been a core member of the Induction Working Group since it was established. Her research interests include the application of in vitro and in vivo models towards developing a mechanistic understanding of the disposition of novel therapeutics.