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Biomarker to Analyze Drug-induced Injuries of Kidney, Liver and the Vascular System
Thomas Joos, Deputy Managing Director, University of Tuebingen, Germany

The presentation will focus on the definition of clinical qualification processes for safety biomarkers and will address our biomarker candidate selection criteria.

Coffee Break and Networking in Exhibition Hall

Overview of Challenges in the Clinical and Pharmaceutical Use of Biomarkers and Future Opportunities
Dolores Cahill, Professor, University College Dublin, Ireland

Despite many biomarker publications, there are many issues and challenges that remain to be overcome to integrate the use of biomarkers in Clinical and Pharmaceutical use. These issues and the opportunities will be discussed.

Regulation of Renal Drug Transport Under Physiological and Pathological Conditions
Rosalinde Masereeuw, Associate Professor, Radboud University Nijmegen Medical Centre, Netherlands

This presentation will give an overview of important drug transporters in renal proximal tubules and focuses on the regulatory pathways that control these transporters.

Technology Spotlight:
Investigating Transporter Function with P-Glycoprotein, MRP2 and BCRP Gene Knockout Caco-2 Cell Models
Ingo Meier, Field Application Specialist, Sigma Life Science

The pharmacokinetic, efficacy and safety profiles of new drug candidates may be significantly affected by interactions with membrane transporters. Although assays currently exist to assess potential interactions for many transporters, these are often limited by the lack of specificity of inhibitors/substrates for a given transporter. To address this need, researchers at Sigma Life Science developed single and double knockout cell lines for the three major intestinal efflux transporters (MDR1, BCRP and MRP2) in a subclone of Caco-2 cells (C2bbe1). This presentation will provide an overview of the technology used to produce these cell lines as well as provide the genetic and functional data used to validate them.

Lunch Break and Networking in Exhibition Hall

Poster Viewing Session

Coffee Break and Networking in the Exhibition Hall

Proteomics-informed Prediction and Modeling of the Role of Drug Transport Proteins in Drug Disposition, Drug-drug Interactions and Adverse Effects
Per Artursson, Professor, University of Uppsala, Sweden

The impact of drug transporting proteins on drug disposition, drug-drug interactions and adverse effects will be discussed in light of the new guidelines for drug-drug interactions from FDA and EMA. Recent technological improvements of in vitro-in vivo correlations will be presented.

Evaluation and Adverse Consequences of Metabolic Bioactivation
Christopher Goldring, Senior Lecturer, University of Liverpool, United Kingdom

This talk will highlight the work carried out at the MRC Centre for Drug Safety Science in the U.K. and in other laboratories, to evaluate the adverse consequences of metabolic bioactivation of drugs, how we adapt to drug exposure, and how the use of biomarkers may help us to bridge our understanding between different established and emerging experimental models.

The Accurate Detection of Genotoxic Carcinogens, and the New Challenges Presented by 'Epi-genotoxicity'
Richard Walmsley, Professor, University of Manchester, United Kingdom

Increased accuracy in the detection of genotoxic carcinogens has resulted from improvements to regulatory tests, and development of new tests. Mitotically transmissable, 'epigenetic' changes in DNA methylation and histone modification present a new challenge. Should we testing for epigenotoxicity?

End of Day One

In Silico Prediction of Toxicity: How Good is it?
John Dearden, Emeritus Professor, Liverpool John Moores University, United Kingdom

The presentation will discuss how well QSAR modelling and similar techniques can predict toxicity end-points, and how well available software performs. Currently some end-points can be predicted reasonably well, but there is still a long way to go.

Challenges and Recent Developments in the Prediction of Metabolites From the Cytochromes P450
Patrik Rydberg, Associate Professor, University of Copenhagen, Denmark

The major challenges in computer-based prediction of drug metabolism will be discussed together with the most recent developments in overcoming these by combining empirical knowledge from experiments with quantum chemical understanding of the reaction mechanisms.

Coffee Break and Networking in Exhibition Hall

HT-MetID:From Data to Information and From Information to Knowledge
Ismael Zamora, Associate Professor, Lead Molecular Design SL, Spain

A new methodology for computer assisted metabolite identification based on High Resolution Mass Spectrometry is present for different metabolic workflows.

Technology Spotlight:
Miniaturization of ADME Assays Using the Labcyte Echo Liquid Handler
Dominik Zahr, Field Application Scientist, Labcyte GmbH

Results generated with Labcyte’s acoustically driven Echo liquid handler will be presented showing that accurate compound profiling can be successfully miniaturized by as much as 10-fold. Dramatic savings in reagent costs, elimination of tip-based artifacts, and high precision and accuracy are all benefits demonstrated in time-dependent inhibition, metabolic stability and transporter studies.

Lunch Break and Networking in Exhibition Hall

Poster Viewing Session

Coffee Break and Networking in the Exhibition Hall

ADME Pharmacogenomics and Cancer: Clinical Consequences and Future Perspectives
Matthias Schwab, Senior Registrar, Institute of Clinical Pharmacology, Germany

ADME pharmacogenomics (PGx) is a core element in personalized medicine in oncology. Its basic concept is that variability in drug response is a consequence of multiple factors, including genomics, epigenomics, the environment and the patient’s characteristics. An ADME systems pharmacology approach needs to be considered in the future.

Close of Conference