Purpose

This workshop will offer a platform for experts to discuss the needs of complementary approaches to understand complex questions focused on biological mechanisms to advance human health and opportunities, to use NIH-funded model resources and physical infrastructure, to validate new approach methodologies (NAMs), and to improve overall predictability of models for human diseases.

Background

Biomedical researchers rely on a combination of innovative methods, models, and technologies to answer complex questions about human health and disease. The use of any given approach is driven by its ability to support rigorous and impactful science and answer the research question under study. Scientific advancements in the last decade led to the introduction of precision animal models, which are carefully designed and engineered to mimic specific human genetic variations and disease characteristics. While animal research remains necessary for addressing the complexity of human biology, rapid advances in technology are catalyzing the development and use of complementary NAMs (which include in silico, in chemico, and in vitro models). NAMs hold tremendous promises for increasing the tools available to achieve the NIH mission and potentially improve significantly the effectiveness of model use in several research areas in the future. Among examples of noticeable application of NAMs is regulatory testing, which includes safety and toxicity testing of pharmaceuticals and chemicals. Non-animal approaches are also being used in the approval process for drugs and vaccines in humans and the testing of the safety of commonly used chemicals. Application of NAMs in general biomedical research areas, such as basic science or preclinical testing, requires significant further development and validation. While some NAMs aim to replace animal testing, others are used in a complementary way with animal studies to gain better insights and solutions to scientific questions, thereby reducing and refining the overall use of animals in research. Given the current state of technology development, realizing the broad utility of NAMs in biomedical research will require sustained investment in shared infrastructure and community resources—such as robust validation frameworks, interoperable data standards and platforms, reference datasets, training, and coordinated access to specialized capabilities—to support their proper incorporation and wide application.

Day One will concentrate on the strategic and translational integration of NAMs and animal models in biomedical research. Discussions will address the complex incorporation of emerging technologies into studies of human disease progression, including the shared infrastructure needed to support adoption (e.g., data standards, interoperable platforms, and validation resources).

Day Two will pivot on the technological frontiers of NAMs that reshape biomedical discovery, focusing on strategies and validation of combined multi-system integration. Sessions will also emphasize how technologies will drive adoption and maximize impact on human disease research, with an interest in identifying infrastructure gaps.

ORIP POCs

Please contact the ORIP staff listed below for more information about the workshop.

Day One
Oleg Mirochnitchenko
Yongjun Sui

Day Two
Monika Aggarwal
Jeffrey Spector