Bio: Anna Goralczyk is the Manager of In Vitro Alternatives laboratories at Philip Morris International. She holds a PhD in Biomedical Engineering obtained from the National University of Singapore, and her over 14-year research experience centers around in vitro cellular models. Anna started her career by developing in vitro models for toxicological testing in an academic environment, as well as for industry collaborations such as with Procter and Gamble. Following that, Anna also worked in the pharmaceutical industry under strict Good Manufacturing Practices policies, which inspired her to see how a defined quality framework can positively influence the reliability of research. This continuous quality improvement is something she now routinely implements in her research laboratories.

Abstract: The adoption of New Approach Methodologies (NAMs) in respiratory research requires robust and well-characterized in vitro test systems and methods to ensure reliability and regulatory acceptance. This session will explore how the OECD Guidance Document 286 – Good In Vitro Method Practices (GIVIMP) can be applied to optimize in vitro respiratory methods, enhancing study reproducibility and data integrity. A case study on the how GIVIMP principles were implemented in an in vitro respiratory lab will be used to demonstrate the practical aspects of applying a new quality standard in a laboratory. Through real-world case studies, attendees will gain practical insights into integrating GIVIMP standards to improve study design, data management, and regulatory compliance. Information on benefits through use of the quality system will be shared to strengthen the case for others to adopt these principles in their own laboratories. The case study of implementing GIVIMP in the In Vitro Alternatives laboratory and later expanding the scope to include the in-house histological processing labs, participants will see how the work performed has been strengthened to improve the reliability of NAM-based approaches for inhalation toxicology, disease modeling, and drug development.