Physiologically-based Pharmacokinetic (PBPK) Modeling | An ISSX 2022 Virtual Workshop Event

Physiologically-based Pharmacokinetic (PBPK) Modeling | An ISSX 2022 Virtual Workshop Event

This workshop has been organized through the efforts of the ISSX Modeling and Simulation Focus Group under the leadership of the Focus Group Chairs, Manthena Varma and Yuan Chen.

This virtual workshop will focus on the advancements in the application of PBPK as a mechanistic tool in the discovery and development setting. The workshop has been structured into three sessions with emphasis on emerging trends such as special population, biomarker-informed DDI modeling, and diverse drug development applications. Each session will include lectures and short presentations, the latter will be selected from the pool of abstracts from the students and industry attendees.

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.

The workshop includes access to all presentation slides and recordings.

  • Session 1: Mechanistic Modeling of PK in Special Population
    Contains 1 Component(s)

    This virtual workshop is focused on the advancements in the application of PBPK as a mechanistic tool in the discovery and development setting.

    Chairs: Yuan Chen, Genentech, and Oliver Hatley, Certara UK Limited, Simcyp Division

    Keynote Lecture:  Overview of Special Population, Physiology, Proteomics of Enzymes and Transporters
    image Jashvant Unadkat, University of Washington, Seattle, Washington, USA

    Organ Impairment PBPK
    image Tycho Heimbach, Merck & Co., Inc, Rahway, New Jersey, USA

    Pediatric PBPK Model
    image     Wen Lin, Janssen R&D, Spring House, Pennsylvania, USA

    Regulatory Perspective on PBPK Modeling of Special Populations
    image Ying-hong Wang, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

    Selected Abstract Presentation: P1. RETROSPECTIVE EVALUATION OF 33 OAT1/3 RENALLY SECRETED DRUGS: IMPLICATIONS FOR PBPK MODELLLNG OF CHRONIC KIDNEY DISEASE
    image     Shawn Pei Feng Tan, University of Manchester, Manchester, United Kingdom

    Selected Abstract Presentation: P2. PHYSIOLOGICALLY BASED BIOPHARMACEUTICS MODELING (PBBM) TO ANTICIPATE PH-MEDIATED DDI RISKS IN SPECIAL POPULATIONS AND TO INFORM FORMULATION DEVELOPMENT
    image     Di Wu, Merck & Co., Inc., Rahway, New Jersey, USA

    Roundtable Discussion with Speakers

  • Session 2: Current State of Biomarker-informed PBPK Modeling to Predict DDIs
    Contains 1 Component(s)

    This virtual workshop is focused on the advancements in the application of PBPK as a mechanistic tool in the discovery and development setting.

    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

  • Session 3: Successful Drug Development Stories and Learnings
    Contains 2 Component(s)

    This virtual workshop is focused on the advancements in the application of PBPK as a mechanistic tool in the discovery and development setting.

    Chairs: Venkatesh Pilla Reddy, AstraZeneca, and Jaydeep Yadav, Merck Research Laboratories

    Recent IQ PBPK Induction Survey Outcome and Current Status
    image Tammie Cabalu, Merck & Co., Inc, Philadelphia, Pennsylvania, USA

    PBPK Joins PMX in fight of COVID-19 Therapeutics
    image Pradeep Sharma, AstraZeneca, Cambridge, United Kingdom

    PBPK Case Studies for Regulatory Submissions Including Consultant Examples
    image     Karen Rowland Yeo, Certara, Sheffield, United Kingdom

    Recent Examples of PBPK from FDA and Implementation of Verification/validation in Reviewing PBPK Submissions
    image Jianghong Fan, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

    Effect of a Ketohexokinase Inhibitor (PF-06835919) on in vivo OATP1B Activity 
    image     Emi Kimoto, Pfizer, Inc, Groton, Connecticut, USA

    Selected Abstract Presentation: P7. THE APPLICATION OF MACHINE LEARNING IN THE PREDICTION OF DRUG-DRUG INTERACTIONS
    Jaidip Gill, Imperial College London, London, United Kingdom

    Roundtable Discussion with Speakers