Abstract

Session Title: An Integrated Approach to Animal-Free Testing Leveraging MPS -- Chairperson: Dr. Danilo Tagle, NCATS

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The NIH Complement to Animal Research in Experimentation (Complement-ARIE) Program to Advance New Approach Methodologies (NAMs)

The 21st century has been a time of accelerated technological advancement. New and evolving methodologies, including gene editing, artificial intelligence (AI), induced pluripotent stem cells (iPSCs), and advanced 3D models are fundamentally changing the way biomedical science is done. These technologies have greatly enabled and contributed to the development and application of New Approach Methodologies (NAMs). NAMs can be defined as any in vitro, in chemico or computational (in silico) method that when used alone, or in concert with others, enables improved chemical and drug safety assessment through more human-relevant models and as a result, can contribute to the replacement of in vivo studies. While animal models continue to be vital to advancing scientific knowledge, NAMs offer unique strengths that, when utilized strategically or in combination, can enable researchers to answer previously difficult or unanswerable questions, especially in areas where in vivo models are lacking or have consistently underperformed.?  

The recent passage into law of the FDA Modernization Act 2.0 enabled drug registration without the absolute requirement for the use of animals in safety toxicology assessment where alternative risk assessment tools are available. An NIH Complement Animal Research In Experimentation (Complement-ARIE) working group (WG) has been engaged in robust strategic planning activities and stakeholder outreach focused on developing a unifying vision for building on ongoing efforts to develop, standardize, validate, and use NAMs, and identifying opportunities for innovation and coordination with other stakeholders.

The overarching goal of the Complement-ARIE program is to catalyze the development, standardization, validation, and use of human-based NAMs that will transform the way we do basic, translational, and clinical sciences.?The program goals include:?

•    Better model and understand human health and disease outcomes across diverse populations.?
•    Develop NAMs that provide insight into specific biological processes or disease states.?
•    Validate mature NAMs to support regulatory use and standardization.?
•    Complement traditional models and make biomedical research more efficient and effective.?
 
Complement-ARIE will significantly advance understanding of human health and etiology of human disease, have near-term application in fields such as mechanism elucidation, precision medicine, safety pharmacology, predictive toxicology, efficacy evaluation of candidate therapeutics, and provide a range of ready and standardized models for health and disease biology.