AAPS Workshop on Quantitative Model-based Drug Development in Drug Discovery and Translational Research

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This workshop is being held in conjunction with the
2009 AAPS Annual Meeting and Exposition.

Goals and Objectives

The area of Preclinical PK/PD Modeling & Simulation encompasses a multitude of quantitative approaches to integrate preclinical pharmacology, biomarker response and safety data toward the selection of the most promising drug targets and the development of the most optimal drug candidates. In recent years, this rapidly evolving area has been recognized as critical for the pharmaceutical companies to reduce high rates of failures in advancing compounds from the bench to the bedside.

In this one-day workshop, we will provide basic education and hands-on training on technical and theoretical aspects of the preclinical PK/PD modeling via a combination of lectures, case studies and break-out sessions demonstrating the key mathematical strategies to build dose-response relationships, efficacy and human dose projections. We will:

  • introduce the concept and fundamental principles of PK/PD modeling and simulation, particularly in preclinical phase;
  • discuss case studies demonstrating the applications and values of preclinical PK/PD modeling within the framework of industrial and academic drug discovery and translational research efforts;
  • provide practical hands-on training on the key aspects of preclinical PK/PD modeling. Topics include PK/PD modeling and simulation for drug target selection, mechanism-based PK/PD modeling for biomarker development, and human dose projection for both small and large molecule (e.g. antibody) compounds; and
  • introduce strategies to overcome challenges associated with the implementation of PK/PD modeling and simulation in drug discovery and development, including silo-structure, interdisciplinary communication and decision-making