Themes and tracks

Scientific Program

Beyond New Frontiers: Innovation in New Approach Methods Using Life Sciences

The WC14 program is built around the core principles of the 3Rs—Replacement, Reduction, and Refinement—and is designed to span the full lifecycle of New Approach Methodologies (NAMs). It encompasses key areas including research, validation, regulatory acceptance, industrial application, education, and global collaboration. With a deliberately broad and inclusive track framework, WC14 fosters contributions from academia, regulatory authorities, and industry alike, creating a collaborative platform that supports diverse perspectives and a wide range of session proposals.

Congress Tracks

Six core tracks are defined:

Focuses on the application of human-relevant models, including organoids, microphysiological systems (MPS), in silico approaches, and AI-enabled tools for safety assessment, efficacy evaluation, disease modeling, and precision medicine. Topics include translational science, predictive performance, and integration into biomedical research and development.

1. Human Health

Scope: NAM-based safety and efficacy assessment using human-relevant models, including organoids, MPS, and in silico approaches, as well as next-generation risk assessment.

Addresses refinement, reduction, and replacement strategies in animal research. Topics include animal welfare, responsible animal research, experimental design, ethical considerations, and innovative approaches that improve scientific quality while minimizing animal use.

2. Animal Welfare

Scope: Refinement, reduction, and welfare in veterinary and animal-use contexts, including alternatives to animal testing.

Explores environmental health, ecotoxicology, and sustainability using non-animal and mechanistic approaches. Discussions include environmental risk assessment, chemical safety evaluation, One Health perspectives, and emerging methodologies for environmental protection.

3. Environmental Health

Scope: Ecotoxicology and environmental safety assessment through mechanistic and non-animal approaches.

Focuses on validation, qualification, regulatory acceptance, and international harmonization of NAMs. Topics include FDA Drug Development Tool (DDT) Qualification Program, ISTAND Pilot Program, OECD activities, regulatory science, implementation strategies, and pathways for integrating innovative methods into regulatory decision-making.

4. Regulatory Acceptance and International Harmonization

Scope: Regulatory acceptance, method validation, and international harmonization of alternative methods.

Covers emerging technologies, industrial implementation, scale-up, automation, digital transformation, and AI-enabled solutions. Topics include AI governance, transparency, trust, reproducibility, and industrial adoption of next-generation methodologies.

5. Emerging Technologies and Industrial Applications

Scope: Industrial implementation, scale-up, and emerging technologies (AI, high-throughput platforms) across all domains.

Focuses on education, training, dissemination, international collaboration, and workforce development to support the adoption of NAMs and the 3Rs. Special emphasis will be placed on Asia-Pacific collaboration, engagement of early-career researchers, and global capacity building.

6. Education and Capacity Building

Scope: Training, dissemination, and capacity building to advance adoption of the 3Rs and NAMs.

*AI, Ethics, Bioethics, One Health, and Public Trust are cross-cutting themes that apply across all scientific tracks rather than being limited to a single track.

Key Takeaways

  • End-to-end coverage: From research to regulatory and real-world application
  • Human-centered paradigm shift in safety and efficacy assessment
  • Strong integration of One Health and global collaboration
  • Balanced participation across academia, regulators, and industry

Expected Impact

The program is designed to support the career development of young scientists by fostering meaningful global networking opportunities and recognizing outstanding research achievements. It aims to strengthen practical, job-relevant skills while creating a sustainable structure supported by sponsorship opportunities such as awards and fellowships. In addition, the initiative will help build an integrated training platform that brings together academia, industry, and regulatory stakeholders.