CDRD is pleased to offer the following training session as part of the workshop component of the CDRD Training Program:
(Absorption- Distribution- Metabolism- Excretion / Pharmacokinetics / Pharmacodynamics/ Toxicokinetics)
Presenters: Dr. J. Greg Slatter, Scientific Director, Pharmacokinetics and Drug Metabolism, Amgen, Inc., Seattle, WA
Dr. Larry C. Wienkers, Executive Director, PKDM, Amgen Inc., Seattle, WA
Dr. George R. Tonn, Director, Department of Drug Metabolism and Pharmacokinetics, Elan Pharmaceuticals, San Francisco, CA
Date: Thursday, April 22
Time: 1:00 – 4:30pm
Location: Life Sciences Institute, Room 1510, UBC Campus
Spaces Available: 50 maximum
The course will provide a high level overview of the role of ADME-PK/PD scientists in industrial drug discovery and development organizations. The focus will be on development strategy and the types of data collected that optimally discern the ADME/PK-related benefits and risks of a given drug candidate.
ADME studies and bioanalytical techniques in PKDM development paradigms (Greg Slatter):
Some definitions, the tools of the ADME trade and the in vivo components of ADME will introduce the world of PKDM and set the stage for the subsequent presentations. A strategic overview of simple drug discovery and development paradigms will be followed by an overview of the effects of the 2008 US FDA guidance “Safety Testing of Drug Metabolites (STDM)” on development strategy. The module concludes with three short topics on the role of ADME Genomics in the study of PKDM aspects of drug safety, efficacy and intersubject variability.
In vitro metabolism techniques to define DDI potential (Larry Wienkers):
An overview of in vitro drug metabolism techniques with a focused assessment of the role of in vitro P450 inhibition studies in the prediction of clinically relevant drug-drug interactions (DDIs). Experimental features which contribute to robust in vitro data and strategies towards removing DDI liabilities from drug discovery leads will be discussed.
Preclinical and Clinical PK/PD/PM/TK (George Tonn)
An overview of how PK is applied in the drug discovery and development setting will be provided. This will include a brief description of PK parameters, the preclinical tools that are used to quantify drug exposure and disposition, and how these data are used to project human PK. The PK of large molecule biotherapeutics and small molecules will be contrasted and the science of PK/PD (pharmacokinetics/pharmacodynamics), relating drug exposure to biomarkers of pharmacological effect, will be introduced. The course concludes with an introduction to population pharmacokinetics highlighting the emerging importance of modeling and simulation (pharmacometrics) in clinical trial design.
Case Studies (All)
An open Q&A session. Short case studies will be available to guide the discussion.