Sharing knowledge has been a core tenet of XenoTech's ideology for the past 25+ years to help the industry understand, prepare for and address ADME/PK & Drug-Drug Interaction concerns. XenoTech is a global Contract Research Organization that provides unparalleled in vitro ADME/DDI experience utilized by 98% of top pharma companies and countless other organizations. For more than 25 years, the company has offered proven drug development expertise in evaluating drug candidates in compliance with regulatory requirements and guidance prior to entrance to market. The company offers a variety of in vitro safety assessment studies for drug candidate evaluation, as well as an extensive selection of products for drug metabolism and pharmacokinetic research.

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Presenter:  Chris Bohl, Ph.D., Global Technical Support Manager

This ADME 101 video provides an overview of different types of subcellular fractions, such as microsomes, S9, cytosol, lysosomes and homogenate, and their unique benefits for use in various types of in vitro ADMET/DMPK & Drug-Drug Interaction studies. This short, information-packed webinar features:

The different types of subcellular fractions
How they are made
Who uses them, for which studies, and why
Advantages of the test systems
Different preparation options
Whether to use a NADPH regenerating system or 1mM NADPH
How tissue is procured and more...

Download slides: https://www.xenotech.com/webinar-slides/sekisui-xenotech-guide-to-subcellular-fractions.pdf
Questions, comments and requests: https://www.xenotech.com/contact-us 
More information on our research services and test systems: https://www.xenotech.com
Other previously aired webinars: https://www.xenotech.com/scientific-resources/webinar-series
Upcoming webinar notifications: https://www.xenotech.com/newsletter-signup
Request a webinar topic: https://www.xenotech.com/scientific-resources/upcoming-webinars

About the presenter: Dr. Chris Bohl received his PhD from the School of Biological Sciences from the University of Nebraska – Lincoln and has been with XenoTech since 2014, first operating as a research scientist before becoming the Senior Manager of Technical Support for Products.

ADME 101 Guide to Subcellular Fractions and When to Use Which Test System

Presenter: Andrew G. Taylor, Ph.D., Manager of Technical Support for Services at XenoTech

Conducting in vitro ADME drug-drug interaction (DDI) studies early on in the drug development process is more than simply a box checking exercise to satisfy regulatory requirements. The information provided by these studies provides a deeper understanding of the molecule to the drug developer helping to inform go or no-go decisions early on. 

Additionally, these studies are important to help prepare for clinical studies by providing data for FIH dose prediction and potential DDI risks. While in vitro ADME DDI studies might appear deceptively simple, maximizing the information gained from them can be complex, and benefits greatly form expert design and interpretation. 

In this presentation we will discuss the main types of in vitro ADME studies that are required by the regulatory agencies, timing on when to conduct these studies, and highlight the importance of proper study design and data analysis.

Request a copy of the slides: 
https://www.xenotech.com/about/events/webinar-design-intricacies-and-decision-making-strategy-for-drug-drug-interaction-studies/
Questions, comments and requests: https://www.xenotech.com/contact-us 
More information on our research services and test systems: https://www.xenotech.com
Other previously aired webinars: https://www.xenotech.com/scientific-resources/webinar-series
Upcoming webinar notifications: https://www.xenotech.com/newsletter-signup
Request a webinar topic: https://www.xenotech.com/scientific-resources/upcoming-webinars

About the Presenter:
Dr. Andrew G. Taylor received his Ph.D. from University of California San Diego. He joined XenoTech as a research scientist in 2017, serving as a Study Director in nonclinical drug interaction contract studies compliance with Good Laboratory in Practices (GLP), OECD Principles of GLP, &/or Japan MOHW GLP Standards and specializing in drug transport and drug metabolism studies. He became the Technical Support Manager for services in 2020 and provides valuable guidance to ensure research needs are being met.

Design Intricacies and Decision Making Strategy for Drug-Drug Interaction Studies

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.

Request a copy of the slides: https://www.xenotech.com/about/events/webinar-highlights-of-the-in-vitro-sections-of-the-draft-ich-drug-interaction-studies-guideline-and-comparison-with-current-guidance/
Questions, comments and requests: https://www.xenotech.com/contact-us 
More information on our research services and test systems: https://www.xenotech.com
Other previously aired webinars: https://www.xenotech.com/scientific-resources/webinar-series
Upcoming webinar notifications: https://www.xenotech.com/newsletter-signup
Request a webinar topic: https://www.xenotech.com/scientific-resources/upcoming-webinars

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.

Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies Guideline and Comparison with Current Guidance

Learn about what CTD Section 2.6.4 consists of, the studies that are expected and how you develop the section over time from discovery to registering the compound. Key topics include:
 - Generation of ADME data for an NCE throughout development
 - Contents of final filing package
 - What ADME data should be contained at the time of IND
 - Types of ADME data typically found in IND
 - Interdependencies with other non-clinical sections
 - Additional detail on human dose projection and DILI liability prediction

This presentation was one of the keynote presentations from XenoTech's XenoTalks™ Seminar Series on the importance of ADME and Drug-Drug Interactions in drug development. You can register for or request a seminar here: https://www.xenotech.com/about/events/2022-seminar-series-the-importance-of-adme-and-ddi-in-drug-development/ or register to receive notifications of future events here: https://www.xenotech.com/contact/newsletter-sign-up/. These fully interactive events provide in-depth presentations from industry experts along with free food and drinks and good conversations. They cover various topics around pharmaceutical non/preclinical testing with specifics on how to effectively move compounds through the development pipeline.

About the presenter:
Griff Humphreys, Ph.D., is on XenoTech's team of external consultants. Prior to consulting, he spent 26 years at Bristol-Myers Squibb Pharmaceutical Company, with the last 12 years leading the Biotransformation Department. He received his graduate training at the University of Virginia in chemistry and completed a postdoctoral fellowship at Vanderbilt University in the Center in Molecular Toxicology. His research interests include the consequences of reactive metabolite formation, development of new analytical methodologies for metabolite detection, reaction phenotyping of CYP- and UGT-catalyzed biotransformations, predictive metabolism and toxicology models, in vitro–in vivo correlations, and strategies for candidate optimization. He has co-authored over 120 refereed manuscripts and numerous reviews and book chapters. Dr. Humphreys is a member of the ISSX and the ACS Chemical Toxicology Division (TOXI). He is on the Editorial Advisory Boards of Drug Metabolism and Disposition and serves as reviewer for multiple additional journals. He has served on the Executive Committee of TOXI since 2008 and most recently as Program Chair for the 2013-2014 National meetings. He is currently a member of the ISSX Council and was a member of the Meeting Organizing Committee for the 22nd NA ISSX Meeting.

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