Conference Day One: Tuesday, 28th February 2012

09:00 Registration & coffee

09:30 Chairman’s welcome & opening address

mertsch Dr. Katharina Mertsch
Section Head In vitro methods
Sanofi-Aventis GmbH, Germany

Overview & regulatory requirements

09:45Regulation Overview: Regulatory requirements and scientific challenges for transporter studies

  • Regulatory requirements EMA/FDA and timing for studies
  • Risk assessments and clinical studies
  • Case studies

mertsch Dr. Katharina Mertsch
Section Head In vitro methods
Sanofi-Aventis GmbH, Germany

10:30ITC focus: ITC paper on drug transporters

  • The most important transporters
  • DDI
  • How should transporters be incorporated in the R&D strategy?

Niemi-Mikko Prof. Mikko Niemi
MD Professor of Pharmacogenetics
Department of Clinical Pharmacology
University of Helsinki, ITC member, Finland

11:00 Refreshment break & networking

11:30Harmonization of regulations: Understanding regulatory demands and striving for harmonization

  • Regulatory overview of all agencies
  • Outlining the major differences between the agencies
  • Discussion
  • What’s next?

Panel discussion:

Moderator:

mertsch Dr. Katharina Mertsch
Section Head In vitro methods
Sanofi-Aventis GmbH, Germany


Participants:

Niemi-Mikko Prof. Mikko Niemi
MD Professor of Pharmacogenetics
Department of Clinical Pharmacology
University of Helsinki, ITC member, Finland

Poirier-Agnes Dr. Agnès Poirier
Group Head Drug Transport
F. Hoffmann-La Roche AG, Switzerland

nospeaker1 Dr. Dietmar Weitz
R&D DSAR / Drug Disposition FF
Sanofi-Aventis GmbH Germany

12:15 Luncheon & networking

Tools for studying transporters

13:45New approach: The use of in vitro BCRP/OATP data to predict rosuvastatin DDI: A static modelling approach

  • Statin DDI and toxicity
  • Involvement of transporters in rosuvastatin disposition & construction of the model
  • Comparison with ITC recommendations & practical examples

Clarke-James Dr. James Clarke
Senior Scientist
GlaxoSmithKline PLC, UK

14:30In Silico models: In-silico models for combining information on disease related changes to drug metabolism and transport

  • Creating virtual organs where drug metabolism and transport is important
  • Required in vitro data to inform the model
  • System related changes of expression and activity of enzymes-transporters
  • Using model-based predictions of disease effects on ADME

A-Rostami-OS1 Dr. Amin Rostami-Hojdegan
Professor of Systems Pharmacology
School of Pharmacy and Pharmaceutical Sciences
University of Manchester, UK

15:15 Refreshment break & networking

Drug transporters in human platelets

15:45Human platelets: Drug transport in human platelets

  • Physiological prerequisites
  • ABC-transporters in human platelets (focus on MRP4)
  • Uptake transport in platelets

Kroemer-Heyo Prof. Heyo K. Kroemer
Professor of Pharmacology and Toxicology & Chairman of the Department of Pharmacology
Ernst Moritz Arndt University of Greifswald, Germany

Drug transporters’ expression according to different groups

16:30Pharmacogenomics: The pharmacogenomics of drug transporters

  • The possible impact of genetic polymorphism of drug transporters in PK
    • Efficancy
    • Toxicity
  • The challenges ahead
  • Pharmacogenomics – what holds the future?

Niemi-Mikko Prof. Mikko Niemi
MD Professor of Pharmacogenetics
Department of Clinical Pharmacology
University of Helsinki, ITC member, Finland

17:15 Chairman’s closing remarks End of day one

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