The Nasty Surprise of a Complex Drug-drug Interaction (DDI)

Recorded: February 2023

This webinar covered mechanisms and examples of complex DDIs, involving both CYPs and transporters, including time-dependent inactivation, in vitro assessment, predicted and observed clinical impact.

Agenda: 

• How do we assess the impact of complex DDIs involving new drug candidates?
  • General principles of modeling the clinical impact of a compound as a victim or perpetrator of a complex DDI
• Is it possible to predict complex DDIs before they happen, and is it worth trying?
  • In vitro models and testing protocols
  • Is it reasonable or even possible to try to predict all possible unexpected complex DDIs?
• What do we mean by complex DDIs and why are they important?
  • Examples of complex DDIs, including molecular mechanisms

Moderated by: 

Mandy Xu - Senior Vice President, ADME at Pharmaron

Speakers:

Chris Bode, Ph.D. - VP of Scientific Affairs at Pharmaron

As VP of Scientific Affairs, one of Dr. Bode’s responsibilities is to capture and disseminate the mission and messages of the company to the world. He has had multiple roles since joining the company known as Absorption Systems at the time, in 2006. He is Study Director for most of the Biopharmaceutics Classification System (BCS) studies conducted in support of numerous BCS-based biowaivers. He has also directed studies focused on transporters, CYP induction, inhibition, and phenotyping, serves as Scientific Reviewer for many other studies, and either directs or provides scientific input into various research projects, grants, and contracts. Previously, Dr. Bode spent seventeen years in the pharmaceutical industry, working on both pharmacokinetics and pharmacodynamics. His Ph.D. in pharmacology is from the University of Colorado, and postdoctoral research was conducted at UC San Diego.

Chunyan Han, Ph.D. - Senior Director, in vitro ADME, DMPK at Pharmaron

Dr. Han is Senior Director in the DMPK department of Pharmaron with 14-years of hands-on and managerial experience in drug discovery and development. Since she joined Pharmaron in 2009, she has made significant contributions in setting up the in vitro ADME platforms especially for all the cell-based assays. Her responsibility now includes project coordination, new assay development and validation, and acting as DMPK lead in integrated drug discovery projects for data interpretation and molecular design. Dr. Han has excellent knowledge of in vitro and in vivo ADMET/PK technologies and mass spec instruments. Her experience covers early stage drug discovery to late stage regulatory DMPK studies for small molecules. In Pharmaron, Dr. Han leads a team in building up cell-based assays, including permeability screening, drug transporter, cell-based metabolism and CYP induction, etc. 

Aleksandra Galetin, Ph.D. - Professor of Translational Pharmacokinetics at University of Manchester

Dr Galetin is a Professor of Translational Pharmacokinetics in the School of Health Sciences, University of Manchester, UK and Deputy Director of the Centre for Applied Pharmacokinetic Research. She is currently ISSX President-Elect, in addition to her service on the ISSX Council and ISSX Scientific Affairs Committee. Dr Galetin holds long-standing leadership position in the International Transporter Consortium (ITC) where she led multiple white papers, defining best practices for the application of endogenous biomarkers and PBPK modelling of transporter-mediated drug-drug interactions among others topics. In 2016, Dr Galetin completed a sabbatical in the US FDA Office of Clinical Pharmacology where she provided expert advice on the PBPK modelling of drug-drug interactions and specific populations in new drug applications. She has published extensively and supervised/mentored over 40 graduate students and postdoctoral research associates.