Strategic Planning

Complement-ARIE Concept Planning 

The NIH conducted planning activities to inform a potential Common Fund research program called Complement Animal Research In Experimentation (Complement-ARIE) aimed at development, standardization, validation, and use of new methods and approaches that will more accurately model human biology, known as New Approach Methodologies (NAMs). These NAMs are intended to more accurately model human biology, and that would complement, or in some cases, replace traditional models, transforming the way we do basic, translational, and clinical sciences.

Complement-ARIE Concept Listening Sessions

As part of the planning activities, the Common Fund hosted three public listening sessions. These listening sessions brought together key representatives from multiple sectors, including industry and academic partners, non-government organization representatives, and U.S. government and international partners, to gain insight into current opportunities and roadblocks in NAM development unique to their fields.  

Sessions explored these questions:

• Where are animal models insufficient to answer questions about human biology and disease? 
• What are the specific areas of science that could benefit from development of human-relevant NAMs? 
• Where do NAMs show promise in modeling population diversity and susceptibility and what additional research is needed to further those objectives? 
• What are the greatest opportunities for progress in NAMs in the next five years? In the next ten years?
• What are current limitations of NAMs and how could they be addressed? 
• What’s needed for successful application and utility of NAMs and what are obstacles to implementation? 
• What are the challenges and needs around validation of NAMs for regulatory application?

Summaries of these listening sessions are publicly available here. 

Complement-ARIE Concept Interagency Retreat

As part of the planning activities, the Common Fund hosted an inter-agency retreat with federal partners to discuss high-priority areas for the NIH to focus on when developing the Complement-ARIE concept and potential opportunities for partnership, collaboration, and coordination. A summary of the interagency retreat can be viewed here.

Complement-ARIE Landscape Analysis

To ensure that the Complement Animal Research In Experimentation (Complement-ARIE) program is focused on the areas of science with the greatest need, and which present the best opportunities for human-based model development, a landscape analysis was required to collect information on ongoing efforts in the NAMs space. 

This analysis focused on describing existing efforts, and highlighting gaps, challenges, and opportunities in the following primary areas of developing human-based models of health and disease:

• In vitro models (e.g., cell lines and organoids)
• In silico models (e.g., multiscale models and digital twins)
• In chemico cell-free models (e.g., biocomputers and high-throughput receptor-ligand screens)
• FAIRness of data needed to train, interpret, and use NAMs (FAIR = findable, accessible, interoperable, reusable) (e.g., findability/accessibility of datasets, data annotation and interoperability, artificial intelligence (AI)-readiness of training data, data ecosystem infrastructure requirements)

Learn more information and view the complete landscape analysis here. 

To learn more about related work being done at NIH, visit: NIH NCATS Tissue Chip for Drug Screening Program.