Session 3: Successful Drug Development Stories and Learnings


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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

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Successful Drug Development Stories and Learnings
Recorded 06/09/2022
Recorded 06/09/2022 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: Yuan Chen, Genentech, and Oliver Hatley, Certara UK Limited, Simcyp Division
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