Day One

Wednesday 21st September, 2011

08:20 Breakfast

08.50 Chair’s Opening Remarks

Improving Concordance From In Vitro To In Vivo Data

09.00 New Approaches and Uses of In Vitro Systems

Confirmed: Donna Mendrick, Director, Division of Systems Biology, National Centre for Toxicology Research, FDA

09.35 Development of In Vivo and In Vitro Systems as Mechanism-Based Models of Drug-Induced Liver Injury (DILI)

Confirmed: John Davis, Senior Director, Group Head - Research Clinical Pharmacology, Pfizer

10.10 Speed Networking Session

11.10 Morning refreshments

11.40 Structural and Physiochemical Basis for Predictive and Biochemical Toxicology: Translating Fixed Chemical Properties to In Vivo Outcomes

Confirmed: Donna Dambach, Director, Investigative Toxicology, Genentech

Integrating In Silico Models Into Pre-clinical Drug Development

12.15 Integrating In Silico Modeling to Support R&D Decision Making for Early Safety Assessment

Confirmed: David Cook, Computational Biology Leader, Associate Director, Global Safety Assessment, AstraZeneca

12.50 Lunch

ADME, PK and Pharmacogenetic Considerations in Pre-clinical In Vitro Assessments

1.50 The Role of Pharmacogenetics in Metabolite Regioselectivity and Potential Impact in Drug Discovery

Confirmed: Dan Rock, Principal Scientist, Pharmacokinetics and Drug Metabolism, Amgen

2.25 In Vitro In Vivo Extrapolation Approach to Predict Human Clearance and Human Dose

Confirmed: Guangqing Xioa, Drug Metabolism and Pharmacokinetics, Biogen Idec

3.00 Simulating CYP3A4-mediated Autoinduction and Midazolam DDI: The PBPK Modeling Approach 

Guoying Tai, Investigator, Drug Metabolism and Pharmacokinetics, GlaxoSmithKline

3.35 Afternoon Refreshments

4.05 Clinical Drug-Drug Interaction Predictions Using In Vitro Human Hepatocyte Assay

Confirmed: Chuang Lu, Associate Director, Millenium Pharmaceuticals

4.40 Applications in Predicting Sequential Metabolism: A Model of Atypical Mechanism-Based Inactivation (MBI) Kinetics with a Furafylline Analog and Cytochrome P450 1A2

Confirmed: Brooke Vandenbrink, Scientist, Biochemistry and Biophysics Group, Department of Pharmacokinetics and Drug Metabolism, Amgen

  Achieving Validation And Regulatory Acceptance Of In Vitro Assays

5.15 Developing Predictive and Reliable In Vitro Assays to Achieve Validation

Confirmed: Hans Raabe, V.P. Director, Laboratory Services, Institute for In Vitro Sciences

5.50  Chair’s closing remarks