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PK/PD Modeling and Simulation in Drug Discovery
Thursday, November 15
8:30 am – 11:00 am
Symposium
ACPE #073-999-07-581-L04
Pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation in drug discovery is a newly emerging field. PK/PD modeling provides a mechanistic understanding of the quantitative relationship between drug exposure and pharmacological effect. This understanding is of paramount importance for correlating in vitro and in vivo potency, validating the use of biomarkers as surrogates for efficacy endpoints, estimating therapeutic index, and finally, bridging animal efficacy models to human disease. All these assessments are vital in building our confidence as drug candidates advance to clinical development. However, PK/PD modeling in drug discovery has not been fully embraced by the pharmaceutical industry partly because of lack of awareness and understanding of PK/PD principles, difficulties in obtaining temporal efficacy or biomarker response for a novel target and labor-intensive experiments involving both in vivo and in vitro pharmacology studies. As a result, the challenge of conducting PK/PD studies in drug discovery is often not analyzing the data itself, but engaging multi-disciplinary teams to prospectively design and conduct such studies to generate the data. Consequently, there is a significant need to heighten the awareness of PK/PD to discovery scientists. This symposium will focus on the value and application of PK/PD modeling and simulation in drug discovery. It will showcase how high-quality and high-impact PK/PD studies are executed during the various stages of drug discovery, and more importantly, how they are used to address issues and influence decision making. The presentations will include basic theory of PK/PD modeling, practical considerations and challenges of conducting PK/PD studies in small and large molecule drug discovery programs. The ultimate goal of the symposium is to demonstrate that PK/PD modeling and simulation is an essential tool in drug discovery, integrating preclinical PK and efficacy data as well as providing a vital link between drug discovery and development.
Moderators
Zheng Yang, Ph.D.
Bristol-Myers Squibb Co.
Richard C. Brundage, Ph.D.
University of Minnesota
PK/PD Modeling in Small Molecule Drug Discovery: Value and Applications
Zheng Yang, Ph.D.
Bristol-Myers Squibb Co.
Overview of PK/PD Modeling in Drug Discovery – Enabling Translational Pharmacology
Ellen Wang, Ph.D.
Pfizer Global Research and Development
Oncology Critical Path Initiative: An Opportunity for Translational Modeling for BioOncology Molecules Dose Selection
Nelson (Shasha) Jumbe, Ph.D.
Genentech
Integration of Preclinical PK/PD to Clinical Studies
Sandeep Dutta, Ph.D.
Abbott Laboratories
