Physiologically-based Pharmacokinetic (PBPK) Modeling
An ISSX Virtual Workshop Event | June 7-9, 2022
Workshop Program-at-a-Glance
Workshop Sessions
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.
Tuesday, June 7, 2022 | 10:00 am - 2:00 pm ET (US)
Session 1: Mechanistic Modeling of PK in Special Populations
Chairs: Yuan Chen, Genentech, and Oliver Hatley, Certara UK Limited, Simcyp Division
10:00 am - 10:05 am | Welcome and Introduction
10:05 am - 10:30 am | Keynote Lecture: Overview of Special Population, Physiology, Proteomics of Enzymes and Transporters
Jashvant Unadkat, University of Washington, Seattle, Washington, USA
10:30 am - 10:50 am | Organ Impairment PBPK - New Cases and Role of Absorption
Tycho Heimbach, Merck & Co., Inc, Rahway, New Jersey, USA
10:50 am - 11:10 am | Pediatric PBPK Model
Wen Lin, Janssen R&D, Spring House, Pennsylvania, USA
11:10 am - 11:25 am | Break
11:25 am - 11:45 am | Regulatory Perspective on PBPK Modeling of Special Populations
Ying-hong Wang, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
11:45 am - 11:55 am | Selected Abstract Presentation: P1. RETROSPECTIVE EVALUATION OF 33 OAT1/3 RENALLY SECRETED DRUGS: IMPLICATIONS FOR PBPK MODELLLNG OF CHRONIC KIDNEY DISEASE
Shawn Pei Feng Tan, University of Manchester, Manchester, United Kingdom
11:55 am - 12:05 pm | Selected Abstract Presentation: P2. PHYSIOLOGICALLY BASED BIOPHARMACEUTICS MODELING (PBBM) TO ANTICIPATE PH-MEDIATED DDI RISKS IN SPECIAL POPULATIONS AND TO INFORM FORMULATION DEVELOPMENT
Di Wu, Merck & Co., Kenilworth, New Jersey, USA
12:05 pm - 12:35 pm | Roundtable Discussion with Speakers
12:35 pm - 12:40 pm | Session Closing Remarks
12:40 pm - 1:00 pm | Break
1:00 pm - 2:00 pm | Poster Session 1
Wednesday, June 8, 2022 | 10:00 am - 2:00 pm ET (US)
Session 2: Current State of Biomarker-informed PBPK Modeling to Predict DDIs
Chairs: Nita Patel, Eli Lilly and Company, and Yurong Lai, Gilead Sciences
10:00 am - 10:05 am | Welcome and Introduction
10:05 am - 10:35 am | Keynote Lecture: Envisioning the Interface of Liquid Biopsy with PK-ADME-DDI PBPK Modeling
A. David Rodrigues, Pfizer Inc., Groton, Connecticut, USA
10:35 am - 10:55 am | Modeling of Endogenous Biomarkers for Renal Drug Transporters in Healthy and Patients with Impaired Renal Function
Aleksandra Galetin, University of Manchester, Manchester, United Kingdom
10:55 am - 11:10 am | Break
11:10 am - 11:30 am | Regulatory Perspective on Transporter and CYP Biomarkers
Xinning Yang, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
11:30 am - 11:40 am | Industry Case Studies for DDI Evaluation with OATP1B Biomarkers
Kenta Yoshida Genentech, South San Francisco, California, USA
11:40 am - 11:50 am | Selected Abstract Presentation: P4. PREDICTING CHANGES IN THE PHARMACOKINETICS OF CYP3A-METABOLIZED DRUGS IN HEPATIC IMPAIRMENT: INSIGHTS INTO FACTORS DRIVING THESE CHANGES
Mayur K. Ladumor, University of Washington, Seattle, Washington, USA
11:50 am - 12:00 pm | Selected Abstract Presentation: P5. PHARMACOKINETIC PREDICTION OF ETANERCEPT IN JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS USING PBPK MODEL
Chie Emoto, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan
12:00 pm - 12:35 pm | Roundtable Discussion with Speakers
12:35 pm - 12:40 pm | Session Closing Remarks
12:40 pm - 1:00 pm | Break
1:00 pm - 2:00 pm | Poster Session 2
Thursday, June 9, 2022 | 10:00 am - 2:00 pm ET (US)
Session 3: Successful Drug Development Stories and Learnings
Chairs: Venkatesh Pilla Reddy, AstraZeneca, and Jaydeep Yadav, Merck Research Laboratories
10:00 am - 10:05 am | Welcome and Introduction
10:05 am - 10:25 am | Recent IQ PBPK Induction Survey Outcome and Current Status
Tammie Cabalu, Merck & Co., Inc, Philadelphia, Pennsylvania, USA
10:25 am - 10:45 am | PBPK Joins PMX in fight of COVID-19 Therapeutics
Pradeep Sharma, AstraZeneca, Cambridge, United Kingdom
10:45 am - 11:05 am | PBPK Case Studies for Regulatory Submissions Including Consultant Examples
Karen Rowland Yeo, Certara, Sheffield, United Kingdom
11:05 am - 11:20 am | Break
11:20 am - 11:40 am | Recent Examples of PBPK from FDA and Implementation of Verification/validation in Reviewing PBPK Submissions
Jianghong Fan, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
11:40 am - 11:50 am | Effect of a Ketohexokinase Inhibitor (PF-06835919) on in vivo OATP1B Activity
Emi Kimoto, Pfizer, Inc, Groton, Connecticut, USA
11:50 am - 12:00 pm | Selected Abstract Presentation: P7. THE APPLICATION OF MACHINE LEARNING IN THE PREDICTION OF DRUG-DRUG INTERACTIONS
Jaidip Gill, Imperial College London, London, United Kingdom
12:00 pm - 12:35 pm | Roundtable Discussion with Speakers
12:35 pm - 12:40 pm | Session Closing Remarks
12:40 pm - 1:00 pm | Break
1:00 pm - 2:00 pm | Poster Session 3