Molecular Predictors of Drug-induced Harm: From Clinical Development to Postmarketing Surveillance

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 26, 8:00AM - 9:30AM

Session Number:
318

Room Number:
152

Level:
Intermediate

Type:
Session

Title:
Molecular Predictors of Drug-induced Harm: From Clinical Development to Postmarketing Surveillance

Chair(s):
Niklas Noren, PhD
Chief Science Officer
Uppsala Monitoring Centre (UMC) , Sweden

Description:
This session will describe opportunities to identify molecular predictors of drug-induced harm in clinical development and postmarketing surveillance. It will outline the potential to predict and assess drug-drug interactions during drug development, based on mathematical models of in vitro and human pharmacokinetic data. In addition, it will present case studies of analytical approaches to discern the molecular basis for reported adverse drug reactions to marketed products and related approaches to de-risking development stage drug candidates, including chemical structures, drug-target affinities, metabolizing enzymes and pathways.

Learning Objective(s):
Identify the relevance and application of drug interaction predictive models to clinical development; Describe the opportunities and challenges presented by molecular-based analyses of drug-induced harm from postmarketing surveillance data.

Presentation(s) & Speaker(s):
Drug-Drug Interactions: Current Regulatory Perspectives and Clinical Relevance
Peter J. Kilford, PhD
Senior Project Manager
Covance Inc. , United Kingdom

Molecular Analysis of Patient Adverse Events
David Brian Jackson, PhD
Chief Scientific Officer
Molecular Health GmbH, Germany

Chemical Structure in Pharmacovigilance: Molecular Predictors of Drug-induced Harm
Niklas Noren, PhD
Chief Science Officer
Uppsala Monitoring Centre (UMC) , Sweden