Priority Area 1: Modernize Toxicology to Enhance Product Safety

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Preclinical testing plays a crucial role in identifying the potential risks associated with new FDA-regulated products. But, serious and unexpected negative side effects are sometimes discovered in clinical trials or once a product is on the market, suggesting that critical gaps exist in our understanding of the relationship between patient response and preclinical toxicology findings.

The extramural research projects funded through the BAA and listed below each illustrate how FDA is working to close these gaps and improve preclinical safety predictions by further investing in three particular areas of regulatory science: evaluating and developing models and assays that better predict patient response; identifying and evaluating more reliable biomarkers for monitoring toxicities, side effects, and abnormalities, and using computational tools to integrate and draw conclusions from a wide range of preclinical safety data types and sources.

Extramural Research Funded through the BAA

1. The Impact of Graphene-Based Nanomaterials (Phases 1 and 2)
2. The Musculoskeletal Atlas Project
3. A Systems Approach to Measuring and Modeling Toxic Response
4. The Diversity Outbred: A Tool to Improve Preclinical Safety Testing and Pharmacogenomic Analysis
5. Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity
6. Scientific and Methodological Advancements in Liquid Biopsies to Further the Development of Lung Cancer-Based Precision Medicine