Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies Guideline and Comparison with Current Guidance
Presenter: Brian Ogilvie, Ph.D, Vice President of Scientific Consulting at XenoTech
In June 2022, the ICH released the first draft of its harmonized Drug Interaction Studies Guideline (M12). The guideline is the result of several meetings of the Expert Working Group since 2018 with the goal of harmonizing member regulatory agencies’ guidelines to create a single guideline that will be used across all member countries. After a review period, the guideline will be adopted in early 2024.
Hear expert Dr. Brian Ogilvie discuss the differences between current in vitro drug-drug interaction guidance from the relevant US FDA, EMA and PMDA guidance documents, and how to plan drug development strategies to meet the ICH M12 guideline.
About the Presenter
As Vice President of Scientific Consulting at XenoTech, Dr. Brian Ogilvie is responsible for operational activities within the Scientific Consulting and Quality Assurance departments, as well as strategic planning for the company in scientifically relevant areas. Dr. Ogilvie obtained his Ph.D. in toxicology from the University of Kansas Medical Center and B.A. in molecular biology from William Jewell College. Brian joined XenoTech in 1997 as a Scientist I and progressed into leadership as the head of the CYP Inhibition Department in 1999, with increasing levels of responsibility, ultimately to the current Vice President role. Dr. Ogilvie also serves as a Volunteer Assistant Professor of Pharmacology, Toxicology and Therapeutics for the University of Kansas Medical Center. He is an author or coauthor on over 50 scientific posters, peer-reviewed publications and book chapters on the topics of drug metabolism, transport and drug-drug interactions, and has represented XenoTech as an invited speaker at various drug metabolism conferences.