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ISSX Workshop: Translating Preclinical Data to Human Clearance and Pharmacokinetics
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10/27/2016 to 10/28/2016
When: Thursday, October 27, 2016
Where: Sheraton Boston Hotel
39 Dalton St
Boston, Massachusetts  02199
United States


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Background

The ISSX Workshop on Human Pharmacokinetic Predictions on October 27-28, 2016 will deliver state-of-the-art science in a focused meeting. Key sessions will include:

  • Gap analyses in human PK/clearance prediction at drug discovery and development stages

  • Methodological aspects of clearance prediction for low clearance and highly bound compounds

  • Predicting clearance mediated by non-CYP metabolizing enzymes

  • Quantitative assessment of hepatobiliary transporter- mediated clearance

  • Human PK/clearance prediction in special populations

Goals and Objectives

Our ability to accurately predict human clearance and pharmacokinetics (PK) is a critical component of drug discovery and development. These predictions impact projection of first human dose and potential for drug-drug interactions, which are important attributes of the risk-benefit assessment framework for candidate selection and the planning of early clinical studies. Furthermore, consideration can be given to the need for dose adjustment in patients vs healthy volunteers and for special populations such as pediatric, hepatic or renally impaired and genetic subpopulations. Predictions can be challenging as a result of potential in vitro-in vivo discrepancies and inter-species differences in the specificities and abundance of enzymes and transporters. Moreover, new challenges for human PK/clearance prediction continue to arise. For example, CYP-mediated clearance is being reduced by chemical manipulation in drug discovery only to be replaced by clearance by drug metabolizing enzymes with which we have less scaling experience. This workshop aims to provide fundamental knowledge on current approaches, examine the utility of in vitro and in vivo experimental systems, discuss modeling approaches in human PK/clearance prediction, focus on the current challenges and offer next steps. The ultimate goal is to facilitate formulation of practical strategies utilized in the pharmaceutical industry for human PK/clearance prediction based on in vitro and animal data, in combination with modeling methods.

Key Objectives:

  • Update the current status and challenges in prediction of human PK

  • Assess the application and regulatory perspectives of PBPK modeling

  • Examine state-of-the-art in vitro technologies, combined with physiologically-based models, to address clearance prediction for low clearance and highly bound compounds

  • Address challenging issues and next steps in PK/clearance prediction for non -CYP enzymes, including UGTs, aldehyde oxidase and carboxylesterases

  • Discuss approaches to predict human hepatobiliary transporter- mediated clearance

  • Examine experimental and modeling/simulation approaches in predicting PK/clearance in special populations for compounds of different BDDCS categories


Who Should Attend

Pharmaceutical scientists, academicians, and regulatory professionals interested in learning about prediction approaches, developing their expertise and gaining a more complete appreciation of using a model-based approach to better understand predicting PK/clearance are encouraged to attend this workshop. A poster session will highlight cutting-edge methodologies in human PK/clearance prediction.


Workshop Organizing Committee

Yingying Guo, Chair - Eli Lilly and Company

Jin Zhou, Co-Chair - Boehringer Ingelheim

Aleksandra Galetin - University of Manchester

Stephen D. Hall - Eli Lilly and Company

Donald Tweedie - Boehringer Ingelheim

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