Toxicology for the 21st Century: What is in the Box for Excipients?

Wednesday, July 8, 2020 - 11:00am

The limitations of animal-based toxicology to predict human health threats are widely recognized. We also are discovering more shortcomings of traditional (human) cell culture such as cell identity, differentiation, genetic stability and mycoplasma infection as well as non-homeostatic and non-physiological culture conditions. The increasing pace of technological developments of modern cell culture and their integration leads to what is called “disruptive technologies” that can lead to the development of alternatives to traditional approaches for product development and safety assessment.

Such technological advances promise to be real “game-changers”. Combined with an increased mechanistic base of reasoning (e.g. Adverse Outcome Pathway concepts), Integrated Testing Strategies and evidence-based methods of data evaluation and integration, a revolutionary change for how we assess the biological effects of substances has been set into motion.

Learning Objectives

  1. Illustrate the limitations of animal-based toxicology to predict human safety
  2. Describe the benefits of “disruptive technologies” on product development and safety assessment
  3. Explore specific examples of emerging technologies and their impact on standardization and reproducibility


Dr. Thomas Hartung

Doerenkamp-Zbinden Professor and Chair for Evidence-based Toxicology
Johns Hopkins University, Bloomberg School of Public Health

Thomas Hartung, MD PhD, is the Doerenkamp-Zbinden-Chair for Evidence-based Toxicology in the Department of Environmental Health and Engineering at Johns Hopkins Bloomberg School of Public Health, Baltimore, with a joint appointment at the Whiting School of Engineering. He also holds a joint appointment for Molecular Microbiology and Immunology at the Bloomberg School. In addition, he holds a joint appointment as Professor for Pharmacology and Toxicology at University of Konstanz, Germany; he also is Director of Centers for Alternatives to Animal Testing (CAAT, of both universities. He is adjunct professor at Georgetown University, Washington D.C.
CAAT hosts the secretariat of the Evidence-based Toxicology Collaboration (, the Good Read-Across Practice Collaboration, the Good Cell Culture Practice Collaboration, the Green Toxicology Collaboration and the Industry Refinement Working Group. As PI, he headed the Human Toxome project funded as an NIH Transformative Research Grant. He is Chief Editor of Frontiers in Artificial Intelligence.
He is the former Head of the European Commission’s Center for the Validation of Alternative Methods (ECVAM), Ispra, Italy, and has authored more than 560 scientific publications.

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