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Physiologically-Based Pharmacokinetic Modeling & Simulation to Support Asciminib NDA Submission & Inform Drug Product Label

Live webinar

Physiologically based pharmacokinetic (PBPK) modeling and simulation has become an established approach to assess drug-drug interaction (DDI) liabilities involving CYP enzymes, with transporters and/or absorption-related mechanisms evolving in its acceptance by regulators. In addition, the use of PBPK modeling in specific populations such as organ impairment populations has been recently highly encouraged by the US FDA.

Successful application of PBPK models during regulatory review can be used in lieu of clinical trials and to inform drug product label. In the recent NDA submission of asciminib (Scemblix©) by Novartis, PBPK simulations replaced over 10 clinical pharmacology studies and played an instrumental role in the approval of two additional doses by the US FDA with no additional clinical pharmacology studies at the date of approval.

This webinar will provide an overview of the development and verification of the asciminib PBPK model as well as its applications focusing on highlights from the regulatory review and the impact on the drug product label.


Speaker

Ioannis Loisios-Konstantinidis

Dr. Loisios-Konstantinidis is currently a Principal Scientist in the Clinical PBPK modeling group at Novartis, Basel, Switzerland. He is pharmacist and received his PhD in Pharmaceutical Sciences focusing on PBPK/PD modeling for waiver of in vivo clinical pharmacology studies from the Goethe University in Frankfurt am Main, Germany as well as his M.Pharm from the University of Athens, Greece. Ioannis has been also trained in pharmacometrics as post-graduate in the University of Marseille, France and University of Berlin, Germany. Since 2020, he has represented Novartis in the IQ consortium and Simcyp focus groups and has been actively contributing in the development and successful approval of new chemical entities by applying modeling and simulation tools. Ioannis has had exposure in interactions with health authorities from the sponsor side as well as working experience in the regulatory agency of Germany, BfArM, as a visiting scientist.

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