Clinical & Pharmaceutical Solutions through Analysis
Where Technology and Solutions Meet

CPSA 2012

Transforming Drug Discovery & Development Through Innovation:
Past, Present and Future

October 1 - 4, 2012
Sheraton Bucks County Hotel
Langhorne, PA


Session Synopsis

Tuesday, 3:15 pm - 4:45 pm

Measuring and Mitigating Transporter Effects on the Disposition of New Drugs

Discussion Leader: Mark Hayward, Active Ingredient Technologies

Several factors are driving the recent growing interest in the field of transporters and their impact on drug disposition. For example, pharmaceutical industry continues to have increasing interest in expanding and optimizing into new physicochemical space (compounds that are both/either more hydrophilic and/or polar in nature) as well as minimizing their CYP mediated metabolic liability for its new chemical entities (NCEs). These trends can lead toward lowered permeability / metabolic clearance characteristics and even greater potential contribution from transporters to NCE disposition in humans. Furthermore, new FDA regulations provide guidance on additional approaches and requirements to assess transporter mediated DDI liabilities for NCEs and this is clearly an urgent and immediate interest for all compounds in the development pipeline. Let there be no doubt; the study and mitigation of transporter properties is a growing need in bringing new drugs to market.

This session explores some of latest in transporter assay optimization, retrospective data analysis, regulatory perspectives, workflows, as well as decision tree / product mitigation strategies encountered across the entire evolution of the drug life cycle. Session will be at least 25% panel discussion with speakers and audience about where we are now and the potential for the future.

Guest Panelists:

Incorporation of Transporter Data into Drug Discovery Screening Cascades
Matt Soars, BMS

Predicting Unbound Intracellular Drug Concentrations in the Presence of Transporters
Swati Nagar, Temple University

Prediction of Human Pharmacokinetics for Compounds that are Substrates for OATP Transporters
James Gosset, Pfizer

Transporter Related Assays / Decision Trees / Regulations / Product Mitigation in Drug Development: 'Bad Times' Are Opportunities to be Good Learners
Sid Bhoopathy, Absorption Systems



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