Session 2: Current State of Biomarker-informed PBPK Modeling to Predict DDIs

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Chairs: Nita Patel, Eli Lilly and Company, and Yurong Lai, Gilead Sciences

Keynote Lecture: Envisioning the Interface of Liquid Biopsy with PK-ADME-DDI PBPK Modeling
image A. David Rodrigues, Pfizer Inc., Groton, Connecticut, USA

Modeling of Endogenous Biomarkers for Renal Drug Transporters in Healthy and Patients with Impaired Renal Function
image Aleksandra Galetin, University of Manchester, Manchester, United Kingdom

Regulatory Perspective on Transporter and CYP Biomarkers
image Xinning Yang, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

Industry Case Studies for DDI Evaluation with OATP1B Biomarkers
image Kenta Yoshida, Genentech, South San Francisco, California, USA

Selected Abstract Presentation: P4. PREDICTING CHANGES IN THE PHARMACOKINETICS OF CYP3A-METABOLIZED DRUGS IN HEPATIC IMPAIRMENT: INSIGHTS INTO FACTORS DRIVING THESE CHANGES
image Mayur K. Ladumor, University of Washington, Seattle, Washington, USA

Selected Abstract Presentation: P5. PHARMACOKINETIC PREDICTION OF ETANERCEPT IN JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS USING PBPK MODEL
image Chie Emoto, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan

Roundtable Discussion with Speakers

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Current State of Biomarker-informed PBPK Modeling to Predict DDIs
Recorded 06/17/2022
Recorded 06/17/2022 The objectives of these sessions are to provide education on the scope and utility of PBPK modeling, to highlight emerging areas and recent direction, and to share success stories and learnings in drug development and regulatory findings. Session Chairs: Nita Patel, Eli Lilly and Company, and Yurong Lai, Gilead Sciences
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