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New approach methodologies for drug discovery.

Wenqiang Liu1, Paul D Pang2, Catherine A Wu1

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New human-centered approaches (NAMs) using stem cells, organoids, and in silico methods are revolutionizing drug discovery. These advanced techniques offer promising alternatives to traditional animal testing, improving success rates and accelerating therapeutic development.

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Area of Science:

  • Biomedical Sciences
  • Pharmacology
  • Toxicology

Background:

  • Traditional animal-based drug discovery exhibits high failure rates.
  • There is a growing need for human-centered New Approach Methodologies (NAMs).
  • Advancements in stem cell, organoid, and in silico technologies support NAMs.

Purpose of the Study:

  • To review recent progress in NAMs across the drug discovery continuum.
  • To identify therapeutic candidates and novel models/technologies.
  • To examine bottlenecks and considerations for translational adoption of NAMs.

Main Methods:

  • Review of stem cell-, organoid-, and in silico-based NAMs.
  • Analysis of progress in disease modeling, drug design, and efficacy testing.
  • Examination of biological, technical, and regulatory challenges.

Main Results:

  • Significant progress in identifying therapeutic candidates using NAMs.
  • Development of advanced models and technologies for preclinical and clinical applications.
  • Identification of key bottlenecks hindering widespread adoption.

Conclusions:

  • NAMs show great potential to redefine drug discovery pipelines.
  • Addressing translational and societal considerations is crucial for responsible adoption.
  • Future human-centric approaches promise to enhance drug development efficiency and success.