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DDI 2018-Program

DDI-2018 SEATTLE:  21st International Conference on Drug-Drug Interactions

THURSDAY, JUNE 14, 2018:  DDI-2018 – DAY 1

 

8:00 AM – 8:15 AM

Welcome Remarks: Albert P. Li, APSciences/IVAL

 8:15 AM – 8:45 AM

Opening Remarks (Ken Thummel, University of Washington; Seattle, WA) SLIDES NOT AVAILABLE

 

Session 1: Regulatory Issues (Chair:  Jash Unadkat)

 8:45 AM – 8:50 AM EXHIBITOR PRESENTATION-IVAL DDI Exhibitor

 8:50 AM – 9:20 AM

Current International and US FDA Guidelines for In Vitro Drug-drug Interaction Evaluation (Odette Fahmi, DDI-Edge Consulting LLC; Shelton, CT) 

 9:20 AM – 9:50 AM

Comparison Between the New US FDA and Japan PMDA In Vitro DDI Guidance: Are we Close to Harmonization? (Brian Ogilvie, Sekisui Xenotech; Kansas City, KS) 

9:50 AM – 10:20 AM – BREAK

10:20 AM – 10:25 AM – EXHIBITOR PRESENTATION-Absorption Systems

10:25 AM – 10:55 AM

ITC White Papers on Transporters (Jash Unadkat, University of Washington) SLIDES WILL BE SENT AT A LATER DATE

10:55 AM – 11:25 AM – SESSION 1 PANEL DISCUSSION

11:25 AM – 1:00 PM – LUNCH

 

Session 2:  Literature and NDA Review (Chair: Jingjing Yu)

 1:00 PM – 1:05 PM – EXHIBITOR PRESENTATION-Envigo

 1:05 PM – 1:35 PM

Critical review of the literature 2017-2018 (final) (Sophie Argon, University of Washington; Seattle, WA)

1:35 PM – 2:05 PM

Clinical Relevance of OATP1B Inhibition: A Comprehensive Review of Preclinical and Clinical Drug Interaction Data (Savannah McFeely, University of Washington; Seattle, WA) SLIDES WILL BE SENT AT A LATER DATE

2:05 PM – 2:35 PM

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; Seattle, WA) 

2:35 PM – 3:05 PM – BREAK

 

Transporters and Antibody Drug Conjugates: A Fresh Perspective (Nagendra Chemuturi, Novartis; Cambridge, MA) SLIDES WILL BE SENT AT A LATER DATE

3:05 PM – 4:05 PM – SESSION 2 PANEL DISCUSSION

END OF DAY 1

 

FRIDAY, JUNE 15, 2018 DDI-2018 – Day 2

 7:00 AM – 8:00 AM – REGISTRATION

 

Session 3: In Vitro In Vivo Correlations (Chair:  Manthena Varma)

 8:00 AM – 8:05 AM – EXHIBITOR PRESENTATION-CYPROTEX

 8:05 AM – 8:35 AM

The Universally Unrecognized Assumption in Predicting Drug Clearance and Organ Extraction Ratio (Les Benet, UCSF; San Francisco, CA)

 8:35 AM – 9:05 AM

Extended Clearance Classification system (ECCS) informed Transporter-mediated Clearance and Drug-Drug Interactions (Manthena Varma; Pfizer) SLIDES WILL BE SENT AT A LATER DATE

9:05 AM – 9:35 AM

Prediction of in vivo hepatic clearance of OATP substrates: a comparison of different IVIVE approaches. (Yuichi Sugiyama; Sugiyama Laboratory, RIKEN Innovation Center, RIKEN, Research Cluster for Innovation, RIKEN; Yokohama, Japan) 

9:35 AM – 10:05 AM – BREAK

10:05 AM – 11:05 AM – SESSION 3 PANEL DISCUSSION

11:05 AM – 1:00 PM – LUNCH BREAK

 

Session 4: Physiologically-based Modeling to Support DDI Risk Assessment (Chair: Jan Wahlstrom)

 1:00 PM – 1:05 PM – EXHIBITOR PRESENTATION-SEKISUI XENOTECH

 1:05 PM – 1:35 PM

Physiologically based Pharmacokinetic Modelling to Investigate Transporter mediated Drug–drug interactions (Sibylle Neuhoff, Certara) SLIDES WILL BE SENT AT A LATER DATE

 1:35 PM – 2:05 PM

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

  2:35 PM – 3:05 PM – BREAK

 3:05 PM – 3:35 PM– EXHIBITOR PRESENTATION-SOLVO BIOTECHNOLOGY

Prediction of Metabolite-mediated DDIs using PBPK (Ian Templeton, Genentech; South San Francisco, CA) 

 3:35 PM – 4:05 PM

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

 4:05 PM – 4:35 PM

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

 4:35 PM – 5:05 PM – SESSION 4 PANEL DISCUSSION

 END OF DAY 2

 

SATURDAY, JUNE 16, 2018 DDI-2018 – Day 3

 

7:00 AM – 8:00 AM – REGISTRATION – SIMULATIONS PLUS

Session 5: Unresolved Issues and Novel Technologies for DDI Evaluation (Chair: Albert P. Li)

 8:00 AM – 8:05 AM – EXHIBITOR PRESENTATION-OPTIVIA

 8:05 AM – 8:35 AM

Transporter Drug-Drug Interactions: An Evaluation of Approaches and Methodologies (Rob Elsby, Evotec; Cheshire, UK)

8:35 AM – 9:05 AM

Under Prediction of Hepatic Clearance from InVitro Studies: Prospects for Resolution (J Brian Houston, University of Manchester, UK) 

9:05 AM – 9:35 AM

Evaluation of Endogenous Biomarkers for Transporter Inhibition: Current State and Future Considerations (Xiaoyan Chu, Merck & Co., Rahway, NJ) SLIDES NOT AVAILABLE

9:35 AM – 10:05 AM – BREAK

 11:05 AM – 11:35 AM

A Comparison of Enterocytes and Hepatocytes in CYP3A4 Inhibition (Albert P. Li, IVAL; Columbia, MD)

 11:35 AM – 12:35 PM – SESSION 5 PANEL DISCUSSION

 

 END OF DAY 3

 END OF CONFERENCE