Reimagining human-centric drug development with new approach methodologies

Area of Science:

• Biomedical research
• Drug development
• Toxicology

Background:

• Most drug candidates fail in clinical trials due to limitations in preclinical models.
• A significant gap persists between animal models and human biology.
• Technological advancements necessitate new methods in drug evaluation.

Purpose of the Study:

• To review emerging biological and computational New Approach Methodologies (NAMs).
• To examine the integration of NAMs in reshaping drug development.
• To discuss regulatory and ethical frameworks for NAM implementation.

Main Methods:

• Synthesis of current biological and computational NAMs.
• Analysis of regulatory reforms, including the FDA Modernization Act 3.0.
• Examination of ethical considerations for human-centered drug development.

Main Results:

• NAMs, including human-derived cells and AI, offer a paradigm shift.
• NAMs are positioned to complement or replace animal testing.
• Integration of NAMs promises more predictive and efficient drug development.

Conclusions:

• NAMs represent a crucial transition towards human-centric drug development.
• Regulatory and ethical frameworks are essential for successful NAM adoption.
• A roadmap is proposed for embedding NAMs into a predictive and ethical infrastructure.