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Molecular Predictors of Drug-induced Harm: From Clinical Development to Postmarketing Surveillance
Program Code:
318
Date:
Wednesday, June 26, 2013
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Niklas Noren,
PhD (SCHNON), Chief Science Officer,
Uppsala Monitoring Centre (UMC), Sweden
Dr Norén is the Chief Science Officer and Head of Research at the Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, in Sweden. He has authored more than 20 scientific articles on the analysis of observational medical data for suspected adverse drug reactions.
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SPEAKER
(S):
Niklas Noren, PhD (SCHNON), Uppsala Monitoring Centre (UMC), Sweden
Niels Christian Bojunga, PhD (SPKNON), Molecular Health GmbH, Germany
Peter J. Kilford,
PhD (SPKNON), Senior Project Manager,
Covance Inc., United Kingdom
Peter completed his PhD in 2009 which focused on the prediction of drug glucuronidation clearance before moving to Covance to work as an In Vitro Study Director and then later as a Project Manager. Peter has specialised in techniques such drug-drug interactions and phase II drug metabolism.
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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.