Cancer remains one of the most pressing health challenges of our time, yet drug development in oncology faces persistent hurdles. Despite billions invested, nearly 90% of drugs that succeed in animal studies ultimately fail in human trials, largely due to the poor translatability of preclinical data. The FDA Modernization Act 2.0, passed in late 2022, marks a pivotal shift by allowing non-animal testing methods to replace animal models in preclinical research.
This change is particularly significant for oncology, where human-relevant models are urgently needed to accelerate the development of safer, more effective drugs and therapies. The Act prioritizes New Approach Methodologies (NAMs)—such as microphysiological systems (organs-on-a-chip), induced pluripotent stem cells, and in silico modeling—that more accurately reflect tumor biology and patient diversity. These innovations promise not only to reduce attrition in cancer drug pipelines but also to create opportunities for more personalized and predictive translational research.
This talk explores what the FDA Modernization Act 2.0 means for cancer research and translational medicine, how NAMs are reshaping preclinical pipelines, and how clinical labs can position themselves competitively by embracing modern informatics tools. Attendees will leave with practical strategies for operationalizing regulatory change while improving efficiency, compliance, and translational outcomes.

Learning Objectives:

1. Identify the key provisions of the FDA Modernization Act 2.0 and their specific impact on research and drug development.

2. Discuss how NAMs such as organs-on-a-chip and in silico models are advancing research.

3. Recognize the operational and regulatory challenges oncology labs and clinical trials face as they implement these new methodologies and learn how a LIMS can support compliance with the FDA Modernization Act 2.0.