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日期: 2025 年 9 月 4 日, 星期四

时间: 11 am ET

产品: Simcyp®

概述

The pharmaceutical industry is transitioning away from animal tests, per the recent FDA Roadmap. Scientists’ need for drug development insights without animals has spurred greater interest in New Approach Methodologies (NAMs), such as in silico modeling and in vitro assays like organ-on-a-chip.

This webinar will explore how Human-on-a-Chip (HoC) systems—combined with physiologically-based pharmacokinetic (PBPK) modeling—enable a powerful, human-relevant approach to predicting safety and efficacy in drug development. Speakers will showcase how HoC data can be translated into in vivo outcomes using biosimulation, with case studies illustrating regulatory and program-level impact.

Who should attend:

  • R&D and translational leaders in biotech and pharma
  • Toxicologists and DMPK scientists
  • Clinical pharmacologists and regulatory professionals
  • Modeling & simulation experts

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Key Learning Objectives:

What you’ll learn:

  • Understand how HoC platforms build on organ-on-a-chip technology and function as NAMs aligned with the FDA roadmap
  • Explore how PBPK modeling interprets and extrapolates HoC data for critical scientific insights
  • Review case studies demonstrating animal-replacement potential
  • Gain practical guidance on implementing NAMs in regulatory submissions

演讲嘉宾:

Dr. Patrick F. Smith

SVP, Translational Science, Certara

Dr. James “J” Hickman

Chief Scientist at Hesperos, Inc

Dr. Stephan Schmidt

Director, Center for Pharmacometrics and Systems Pharmacology at University of Florida

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