July 5, 2023
Nicole Kleinstreuer, PhD, the director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the executive director of the congressionally mandated Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). spoke on July 18th, 2023. Dr. Kleinstreuer discussed a topic very important to our industry; a framework comprising five essential elements to establish scientific confidence in NAMs for regulatory use.
What you’ll learn:
- Understanding the needs of regulatory decision makers will facilitate development of relevant NAMs.
- Flexible, fit-for-purpose approaches to establishing confidence in NAMs are necessary to ensure regulatory consideration and implementation.
- Examples will be presented that embody the key concepts involved in applying such a scientific confidence framework.
About our Speaker:
Nicole C. Kleinstreuer, Ph.D.
Dr. Nicole Kleinstreuer is the director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), which is the US federal resource for alternatives to animal testing, and the executive director of the congressionally mandated Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). Her work is centered on domestic and international efforts to develop novel testing, modeling, and analysis strategies that provide more rapid, mechanistic, and human-relevant predictions of potential environmental chemical hazards. Dr. Kleinstreuer has a secondary appointment in the NIEHS Division of Intramural Research Biostatistics and Computational Biology Branch, and adjunct faculty positions in the Yale University School of Public Health and the Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill. She has published over 125 peer-reviewed publications and won numerous awards, including the 2022 NIH Director’s Award and the 2019 Society of Toxicology Achievement Award.
Abstract:
Robust and efficient processes are needed to establish scientific confidence in new approach methodologies (NAMs) if they are to be considered for regulatory applications. NAMs need to be fit for purpose, reliable and, for the assessment of human health effects, provide information relevant to human biology. They must also be independently reviewed and transparently communicated. Ideally, NAM developers should communicate with stakeholders such as regulators and industry to identify the question(s), and specified purpose that the NAM is intended to address, and the context in which it will be used. Assessment of the biological relevance of the NAM should focus on its alignment with human biology, mechanistic understanding, and ability to provide information that leads to health protective decisions, rather than solely comparing NAM-based chemical testing results with those from traditional animal test methods. However, when NAM results are compared to historical animal test results, the variability observed within animal test method results should be used to inform performance benchmarks. Building on previous efforts, this paper proposes a framework comprising five essential elements to establish scientific confidence in NAMs for regulatory use: fitness for purpose, human biological relevance, technical characterization, data integrity and transparency, and independent review. Universal uptake of this framework would facilitate the timely development and use of NAMs by the international community.
About ScitoVation:
ScitoVation helps clients assess chemical compound safety using innovative science, next-generation technology, and professional expertise. ScitoVation is known for partnership, flexibility, and proven success in its work to develop safer and more effective pharmaceuticals, food ingredients, agricultural chemicals, commodity chemicals and consumer products. A spin-off of the former The CIIT and The Hammer Institutes for Chemical & Drug Safety Sciences, ScitoVation is an industry leader of New Approach Methods (NAMS) for chemical/drug discovery & development in the rapidly evolving global regulatory landscape.