PMWS: Physiologically-based Pharmacokinetic Analyses: Practical Applications in Clinical Drug Development
Saturday, September 7th | 8:00 AM – 5:00 PM ET | CE: 6 |
Location: Grand Ballroom HCo-chairs
Kacey Anderson, PhD, Director, Clinical Pharmacology, Terns Pharmaceuticals IncSumit Basu, PhD, Senior Principal Scientist, Pharmacokinetic Sciences, Novartis
Target AudienceThis full-day Workshop will be valuable for beginner to intermediate level physiologically-based pharmacokinetic (PBPK) users and those seeking updated information on current topics in PBPK modeling. The Workshop is designed for doctorate-level students (MD, PharmD, PhD, etc.), postdoctoral fellows and professionals at any career stage. The audience should have a foundational understanding of how to leverage PBPK modeling in support of drug development decisions. The target audience may either work directly with clinical data on a daily basis or are interested in enhancing their skills and knowledge in applying state-of-the-art PBPK methods in drug development. This Workshop is applicable to participants across academia, industry and regulatory settings.
Workshop DescriptionPBPK modeling and simulation is a computer modeling approach that is widely used throughout clinical drug development to describe the PK properties of a drug and to assess intrinsic and extrinsic factors that may impact the PK properties of a drug. This full-day Workshop will focus on current scientific thinking and practical considerations to apply PBPK modeling in clinical drug development. Various software platforms utilized in PBPK modeling will be presented. Attendees will learn how PBPK modeling can be used to facilitate decision making and inform more efficient clinical study design. Attendees will also have the opportunity to learn through real-world case examples of direct application of PBPK modeling in drug development. In addition, regulatory perspectives on the use of PBPK modeling to support new drug applications will be presented and discussed.
Educational Objectives
- Apply PBPK modeling in drug development based on evolving standards and practices and establish PBPK models using various software platforms;
- Analyze the impact of extrinsic factors (such as food-drug and drug-drug interactions) on the pharmacokinetic properties of drug candidates using PBPK models;
- Apply PBPK models for dosing recommendations in special populations, such as pregnancy, organ impairment and disease.
8:00 – 8:30 AMAn Introduction to PBPK & Its Utilization in Clinical Drug Development
Kacey Anderson, PhD, Director, Clinical Pharmacology, Terns Pharmaceuticals Inc8:30 – 9:30 AMInterspecies Scaling Approach Using PBPK ModeIling
Hannah M. Jones, PhD, Senior Vice President, PBPK Consulting, Certara UK Ltd9:30 – 9:45 AMNetworking Break
9:45 – 11:15 AMPBPK Modeling Applications in Special PopulationsRobert Bies, PharmD, PhD, Professor, Pharmaceutical Science, Univ at Buffalo11:15 – 11:30 AMDiscussion, Questions & Answers from Morning Session
11:30 AM – 1:00 PMLunch Break
1:00 – 2:00 PMPrediction of Formulation Effects & Clinical DDIs Using PBPK ModelingHannah M. Jones, PhD, Senior Vice President, PBPK Consulting, Certara UK Ltd2:00 – 3:00 PMApplication of PBPK Modeling for Large MoleculesSumit Basu, PhD, Senior Principal Scientist, PK Science, Novartis
Jongbong Lee, PhD, Associate Director, Pharmacokinetic Sciences, Novartis3:00 – 3:15 PMNetworking Break3:15 – 4:15 PMRegulatory Perspectives on the Use of PBPK Modeling
Yuching Yang, PhD, Lead Pharmacokinetticist, CDER/OCP/DCM, US Food & Drug Administration4:15 – 5:00 PMDiscussion, Questions & Answers, Learner Feedback & Evaluations
