ISSX Workshop 2023 – Small Molecule Metabolites in Drug Discovery and Development
This virtual workshop will focus on the impact of small organic molecule metabolism science on both drug discovery and drug development. Some of the exciting topics to be covered are: the importance of drug metabolites, analytical techniques of metabolite ID, prediction of human circulating metabolite profiles, metabolite biosynthesis, human ADME study strategies and impact, and both the pharmaceutical industry and regulatory perspectives on the value of human ADME studies and drug metabolism science.
Program
Wednesday, March 1, 2023 | 10:00 am – 3:30 pm ET (US)
Session 1
10:00 am – 10:05 am | Welcome and Introduction
10:05 am – 10:45 am | Why Drug Metabolites Can be Important; Examples of Active and Toxic Metabolites
Rheem Totah, University of Washington
10:45 am – 11:30 am | Modern Method of Metabolite ID: Part 1. HRMS: Instrumentation, Strategies
Mark Cancilla Merck & Co., Inc
11:30 am – 11:45 am | Break
11:45 am – 12:30 pm | Modern Method of Metabolite ID: Part 2. 1D and 2D NMR
Greg Walker, Pfizer
12:30 pm – 1:15 pm | Predicting Human Metabolites from Pre-clinical Information and Models – Qualitative and Quantitative
Ernie Callegari, Pfizer
1:15 pm – 2:00 pm | Accessing Metabolites of Various Types – Biosynthesis, Isolation Methods
Speaker to be confirmed
2:00 pm – 2:30 pm | Break
2:30 pm – 3:30 pm | Roundtable Discussion with Speakers
Thursday, March 2, 2023 | 10:00 am – 3:30 pm ET (US)
Session 2
10:00 am – 10:05 am | Welcome and Introduction
10:05 am – 10:45 am | The human ADME study – Comparison of Various Strategies and Technical Approaches
Ulrike Glaenzel, Novartis
10:45 am – 11:30 am | Technical Aspects of AMS – Deep Dive on How AMS Actually Works
Stefan Blech, Boehringer Ingelheim
11:30 am – 11:45 am | Break
11:45 am – 12:30 pm | How to Deal with Metabolites from Human ADME: Part 1. MIST
Yuexia Liang, Merck & Co.
12:30 pm – 1:15 pm | How to Deal with Metabolites from Human ADME: Part 2. Target Activity, DDI, and Modelling Impact Relative to Parent Drug
Speaker to be confirmed
1:15 pm – 2:00 pm | Roundtable Discussion with Speakers
2:00 pm – 2:30 pm | Break
2:30 pm – 3:30 pm | Poster Session 1
Friday, March 3, 2023 | 10:00 am – 3:30 pm ET (US)
Session 3
10:00 am – 10:05 am | Welcome and Introduction
10:05 am – 10:45 am | Regulatory Perspective on the Value of ADME Studies and Drug Metabolites
Douglas Spracklin, Pfizer
10:45 am – 11:30 am | FDA Perspective
Xinning Yang, US FDA
11:30 am – 11:45 am | Break
11:45 am – 12:30 pm | Vignette 1
Simone Schadt, F. Hoffmann-La Roche Ltd.
12:30 pm – 1:15 pm | Vignette 2
Speaker to be confirmed
1:15 pm – 2:00 pm | Roundtable Discussion with Speakers
2:00 pm – 2:30 pm | Break
2:30 pm – 3:30 pm | Poster Session 2