Humanized Animals, or Humans as a New Animal Model: Competing Alternatives in (Pre-)clinical Trials

• In Event: Products of Biotecnoscience: Modified Living Beings Used in Health and Agriculture Activities - I

Abstract

We don’t know how medicines are exactly working inside human body before testing them in an actual human body. How are they absorbed, distributed, metabolized, and excreted, and how are the pharmacokinetic and pharmacological profiles changed through time after administration? Are they safe or not? We don’t have answers before a clinical study, but we cannot perform the study if the safety has not been confirmed. Animal testing seems an unavoidable sacrifice for the purpose.
However, the problem is that most of the drugs with excellent data in animal models do not work for human patients. Several alternatives have been developed with different strategies: Improve the current method of animal studies; Make more human-like animals, so called “Humanized animal model”; Make artificial in vitro tissues and organs resembling human system, so called an “organoid” and “(organs) on-a-chip”; and Add one further stage (“Phase 0”) in the current clinical trial system using human subjects.
This paper discusses the multifaceted implications of these contesting alternatives not only in the (pre)clinical study itself, but also in the wider contexts of the clinical trials, in which the right selection of the research subjects for a certain medicine have been emphasized recently: “Caucasian” vs. “Asian” vs. “Black” vs. ‘Hispanic”, patients with specific mutations, or biological characteristics represented by biomarkers. By doing so, this study would contribute to the STS discussions of precision medicine and the alternatives of the current animal model as an infrastructure of biomedical knowledge making.

Author

• Sungwoo Ahn, Virginia Tech