Speakers: Tycho Heimbach, Merck; Karen Yeo, Certara; Venkatesh Pilla Reddy, AstraZeneca; Viera Lukacova, Simulations Plus; Dwaipayan Mukherjee, Abbvie; Prakash Bolleddula, EMD Serono; Aleksandra Galetin, University of Manchester; Alice Ke, Certara; Yuching Yang, FDA
Organizers: Prakash Bolleddula, PhD
Date: 2022-05-12- 05/13/2022
Time: 12:00-16:30 Eastern Time
Registration fee: Free
Location: Online via zoom
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2022-05-11  (it will close sooner if the seating cap is reached)

About the Topic

Model informed drug development (MIDD) is taking a central role in drug discovery and development. MIDD is an approach that integrates diverse data sources (compound information, disease mechanism and patient characteristics etc.) through a mathematical framework that can be used to quantitatively predict/extrapolate various untested scenarios with an objective of decreasing uncertainty and increasing confidence in drug development.  Physiologically based pharmacokinetic (PBPK) modeling is one such a platform that is being extensively used to predict the effects of extrinsic factors (e.g., drug-drug, drug-food interactions) and intrinsic factors (e.g., organ impairment, disease, age) on drug exposure. This workshop aims to provide an overview on the current status of PBPK modeling and its applications to address various drug development questions and learn about regulatory perspectives.  

• Status of absorption mediated DDI prediction with PBPK modeling and regulatory guidance
• Challenges and opportunities for prediction of CYP and transporter mediated DDIs 
• Progress made in PBPK model guided pediatric dose selection 
• New developments in prediction of pharmacokinetics in special population
• Regulatory perspective of PBPK modeling acceptance in lieu of clinical DDI studies 

May 12th

May 13th