Complement-ARIE: Catalyzing the Development and Adoption of New Approach Methodologies

Area of Science:

• Toxicology and pharmacology research.
• Biomedical sciences and drug development.
• Regulatory science and standardization.

Background:

• New Approach Methodologies (NAMs) are increasingly vital in research, offering alternatives and complements to animal testing.
• The National Institutes of Health (NIH) has significantly boosted investment in diverse NAMs, including in chemico, in silico, and in vitro systems.
• Existing NAMs require further development, standardization, and validation for broader application.

Purpose of the Study:

• To introduce the NIH Common Fund's Complement Animal Research In Experimentation (Complement-ARIE) program.
• To outline the program's goals: advancing combinatorial NAMs for accurate human biology modeling, population-specific outcomes, and regulatory acceptance.
• To detail strategic planning activities informing Complement-ARIE's implementation.

Main Methods:

• NIH organized strategic planning, including an inter-agency retreat, public listening sessions, and literature analysis.
• A challenge prize was utilized to stimulate innovation in NAM development.
• Analysis of scientific literature to understand the current landscape of NAMs.

Main Results:

• Strategic planning identified key scientific and operational opportunities and challenges for NAM implementation.
• Findings will guide the development, standardization, validation, and regulatory use of NAMs.
• The program aims to enhance the efficiency and effectiveness of research by complementing traditional animal models.

Conclusions:

• The Complement-ARIE program is poised to catalyze innovation in NAMs.
• Successful implementation will lead to broader acceptance and impact of NAMs in basic, translational, and clinical sciences.
• These advancements are expected to transform scientific research methodologies.