Human disease models in drug development.

Area of Science:

• Biomedical research
• Translational science
• Drug discovery

Background:

• Current drug development faces high failure rates.
• Traditional animal models exhibit significant interspecies differences and poor predictive value for human conditions.
• A paradigm shift towards human-centric disease models is underway.

Purpose of the Study:

• To review the application of bioengineered human disease models in preclinical and clinical studies.
• To highlight the benefits of organoids, bioengineered tissue models, and organs-on-chips.
• To propose a framework for accelerating clinical translation and drug development.

Main Methods:

• Review of preclinical and clinical studies utilizing bioengineered human disease models.
• Focus on organoids, bioengineered tissue models, and organs-on-chips.
• Development of a high-level design framework for clinical translation.

Main Results:

• Bioengineered human disease models demonstrate high clinical mimicry.
• These models have shown benefits in various preclinical and clinical studies.
• A framework is proposed to guide the use of these models.

Conclusions:

• Bioengineered human disease models are crucial for bridging the translational gap in drug development.
• Organoids, tissue models, and organs-on-chips represent key advancements.
• Implementing a structured design framework can accelerate the development of effective therapeutics.