Presenter: Griff Humphreys, Ph.D., XenoTech Consultant
Presentation Overview:
- Generation of ADME data for an NCE throughout development
- Contents of final filing package
- Considerations for 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
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About the Presenter:
Griff Humphreys is currently Principal with Aranmore Pharma Consulting. Prior to that 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.
Areas of Expertise: CYP- and UGT-catalyzed biotransformations, predictive metabolism, strategies for candidate optimization
