Summary
The CDISC Standard for Exchange of Nonclinical Data (SEND) has enabled the generation and exchange of structured, interoperable toxicology study datasets, providing a foundation for the development of innovative new applications of data science techniques in regulatory toxicology. One emerging application is the use of virtual control groups (VCGs), which leverage historical control data to reduce or replace the use of concurrent control animals in toxicology studies. Projects such as the IHI VICT3R initiative are using SEND-formatted toxicology study dataset repositories to develop robust matching criteria, e.g., study design, dosing regimen, and animal characteristics, to ensure appropriate VCG selection.
However, implementation of VCGs introduces significant challenges, including:
- the need for rigorous terminology reconciliation to integrate data across studies
- the risks of spurious selection of outlier animals
- variability in histopathology diagnostic thresholds – an issue that may require pathologists to re-read slides to ensure accurate interpretation
Fortunately, solutions are available, ranging from tools that automate terminology reconciliation to Bayesian methods that borrow information from historical control data to improve statistical power without direct one-to-one substitution.
By addressing these challenges, SEND-driven innovations can maximize data utility, reduce redundancy, and advance the 3Rs (Replacement, Reduction, Refinement). This presentation will highlight methodologies, obstacles, and future directions for integrating SEND-enabled data science into pragmantic regulatory toxicology strategies.
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Kevin Snyder, PhD
Director of Nonclinical Innovation and Emerging TechnologiesKevin Snyder recently served at FDA/CDER as the Associate Director of Nonclinical Informatics, where he managed data science and informatics initiatives to support the pharmacology/toxicology review program. These initiatives included research efforts to develop methods to optimize the regulatory use of standardized electronic CDISC-SEND-formatted toxicology study data as well as internal informatics projects to promote the development of scientifically sound, data-driven regulatory policies. Kevin has joined Certara in a new role as Director of Nonclinical Innovation and Emerging Technologies, guiding pharmaceutical sponsors in their efforts to strategically integrate nonclinical data across all phases of pharmaceutical development and enhance new drug safety. Prior to this transition, Dr. Snyder had served in various roles at the FDA: first in CDRH as a bioinformatician and in vitro diagnostic device reviewer and then as pharmacology/toxicology reviewer in CDER. He has played a leading role in several precompetitive consortia, including the Pistoia Alliance, CDISC, PHUSE, VICT3R, and BioCelerate, supporting efforts to enhance the implementation and utilization of standardized toxicology study data. Kevin is a dedicated advocate for the modernization of regulatory toxicology via strategic adoption of data standards and data science techniques to drive innovation in areas such as predictive modeling, virtual controls, and new approach methodologies (NAMs).
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