DDI 2018 Program

DDI-2018

21st International Conference on Drug-Drug Interactions:

June 14 – 16, 2018

Husky Union Building, University of Washington; Seattle, WA, USA

4001 NE Stevens Way, Seattle, WA 98195

(206) 543-8131

 REGISTRATION DISCOUNT UNTIL MAY 14, 2018

ISC, INC.

9221 Rumsey Road, Suite # 8

Columbia, Maryland  21045 USA

Opening Remarks:
• Current Hot Issues for DDI (Ken Thummel, University of Washington, Seattle)

Session 1: Regulatory Issues (Chair: Jash Unadkat)
• Current International and US FDA Guidelines for In Vitro Drug-drug Interaction Evaluation (Odette Fahmi, DDI-Edge)

• Comparison Between the New US FDA and Japan PMDA In Vitro DDI Guidance: Are we Close to Harmonization? (Brian Oglivie, Xenotech)

• ITC White Papers on Transporters (Jash Unadkat, University of Washington)

Session 2: Literature and NDA Review (Chair: Jingjing Yu)
• Review of the 2017-2018 Literature on Drug Interactions (Sophie Argon, University of Washington)

• Clinical Relevance of OATP1B Inhibition: A Comprehensive Review of Preclinical and Clinical Drug Interaction Data (Savannah McFeely, University of Washington)

• What Can Be Learned from Recent NDAs? Key Findings on Drug Interactions for Drugs Approved by the FDA in 2017 (Jingjing Yu, University of Washington)

Session 3: In Vitro In Vivo Correlations (Chair: Manthena Varma)
• The Universally Unrecognized Assumption in Predicting Drug Clearance and Organ Extraction Ratio (Les Benet, UCSF)

• Extended Clearance Classification system (ECCS) informed Transporter-mediated Clearance and Drug-Drug Interactions (Manthena Varma, Pfizer)

• Prediction of In Vivo Hepatic clearance of OATP Substrates: A Comparison of Different IVIVE Approaches (Yuichi Sugiyama, Riken)

Session 4: Physiologically-based Modeling to Support DDI Risk Assessment (Chair: Jan Wahlstrom)
• Physiologically based Pharmacokinetic Modelling to Investigate Transporter mediated Drug–drug interactions (Karen Yeo, Certara)

• Physiologically Based Pharmacokinetic Modeling of Transporter-Mediated Hepatic Clearance and Liver Partitioning of OATP and OCT Substrates (Yurong Lai, Gilead)

• Impact of PBPK on Drug Labeling (Mageshwar Budha, Genentech)

• Prediction of Metabolite-mediated DDIs using PBPK (Ian Templeton, Certara)

• Strategies for Developing and Validating PBPK Models for Extrapolation to Unstudied Population (Nina Isoherranen, University of Washington)

• Predicting DDIs for non-CYP enzymes (Jan Wahlstrom, Amgen)

Session 5: Unresolved Issues and Novel Technologies for DDI Evaluation (Chair: Albert P. Li)
• Transporter Drug-Drug Interactions: An Evaluation of Approaches and Methodologies (Rob Elsby, Evotec)

• Assessment of Transporter-mediated Drug-drug Interactions: Implications of Unresolved Issues (Brian Houston, University of Manchester)

• Evaluation of Endogenous Biomarkers for Transporter Inhibition: Current State and Future Considerations (Xiaoyan Chu, Merck)

• Transporters and Antibody Drug Conjugates: A Fresh Perspective (Nagendra Chemuturi, Novartis)

• Impact of Measured, Free, and Intracellular Perpetrator Concentrations from Human Hepatocyte Induction Studies on Drug-Drug Interaction Predictions (Niresh Haripasad, Vertex)

• A Comparison of Enterocytes and Hepatocytes in CYP3A4 inhibition (Albert P. Li, IVAL)