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Discovery and Basic Research
Partner Presentation

Complex In Vitro Lung NAMs for Regulatory Safety Assessment of Inhaled Chemicals

Tuesday, November 11, 2025
1:30 PM - 2:30 PM CT
Location:360 Stage #3, Exhibit Hall

Sponsored By 
Discovery and Basic Research Partner Presentation DBR

Description: Recent developments in the scientific industry underscore the rising importance of New Approach Methodologies (NAMs) in the drug development journey. In April 2025, the U.S. FDA unveiled a landmark roadmap designed to “reduce, refine, or potentially replace” traditional animal testing with “human-relevant methods”, similarly the European Medicines Agency issued a reflection paper revisiting animal-based testing mandates and highlighting opportunities for applying the 3Rs. Together, these examples represent a global shift toward more ethical, efficient, and human-relevant approaches, making NAMs a pivotal component in shaping the future of drug development.

This presentation will provide insight into the introduction of NAMs at CRL, including an overview of the strategic Alternative Methods Advancement Project, details of lung NAMs – focusing on those NAMs already used in regulatory decision making on a case-by-case basis – and finally, provide an update data to validate and qualify a complex lung 3D model for regulatory acceptance in place of acute inhalation studies (performed in collaboration with MatTek and funded by American Chemical Council).

Learning Objectives:

  • • An understanding of the role CROs play in the regulatory acceptance of NAMs for discovery and safety assessment
  • • Overview of lung in vitro models and the importance of computational models to evaluate in vivo lung deposition from in vitro data
  • Using the Interagency Coordinating Committee on the Validation of Alternative Methods framework to develop strategies for the validation of Lung NAMs for broader application following acute inhalation exposure.