Speakers: Hannah Jones (Pfizer), Patrick Trapa (Pfizer), Karen Rowland-Yeo (Simcyp), Manthena Varma (Pfizer) Chirag Patel (Takeda Pharmaceuticals), Dhaval K. Shah (The State University of New York at Buffalo) and Ping Zhao (FDA)
Organizers: Andy Zhu (Takeda Pharmaceuticals)
Date: 2016-10-03
Time: 8:30-16:30 Eastern Time
Registration fee: (USD): Regular: $175; For Academic / unemployed: $125
Location: Courtyard by Marriott Boston Cambridge, 777 Memorial Dr, Cambridge, MA 02139
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2016-09-29  (it will close sooner if the seating cap is reached)

About the Topic

Workshop Description:

The application of physiologically based pharmacokinetic (PBPK) modeling is rapidly expanding within the pharmaceutical industry and has become an important part of drug discovery and development. At this workshop, experts from industry, academia and the FDA will discuss the fundamentals of PBPK, its application at different stages of drug development, and case examples as well as current challenges.

Agenda:

The following topics will be discussed:

• An overview of the application of PBPK in an industry setting: confidence, limitations, and challenges.
• Case studies of using PBPK to predict complex DDI and pharmacokinetic differences in special populations
• Integrating PBPK with PopPK – the impact of PBPK on oncology drug development from a clinical pharmacology perspective
• Application of PBPK modeling for transporter related human PK projections and DDI predictions
• Mechanistic modeling of monoclonal antibodies and antibody-drug conjugate
• FDA’s perspective on the application of PBPK in drug discovery and development