Unique Chance Has Been Created by Nature

A paradigm of stringent correlation between architecture and functionality applies to all levels of biological existence on Earth. These levels of increasing biological complexity appeared step by step during a multi-million year process of evolution. Existence was most likely triggered by slight changes of the external environment which, in turn, created the ability for self-assembly to the next level of complexity. For humans, molecules, cells, sub-organoid tissues, organs, systems, and finally the individual organisms themselves, were thought to represent these levels.

For a long time, the role and function of the sub-organoid structures in man were underestimated, but today it has been proven that almost all organs and systems are built up by multiple, identical, functionally self-reliant, structural units. Interestingly, these sub-organoid units are ofvery small dimensions, ranging from several cell layers to a few millimeters. A small selection of examples of such human sub-organoid structures, all with a prominent functionality and highly variable conglomerate geometry, are listed in Table 11.1.

Due to distinguished functionality, a high degree of self-reliance and multiplicity of such micro-organoids within the respective organ, their reactivity pattern to drugs and biologics seems representative of the whole organ. Nature created very small, but sophisticated, biological structures to realize most prominent functions of organs and systems. The multiplication ofthese structures within a given organ is Nature's risk-management tool to prevent the total loss of functionality during partial organ damage. In evolutionary terms, however, this concept has allowed the easy adjustment of organ size and shape to the needs of a given species (e.g., liver in mice and man), while still using almost the same master plan to build up the single functional micro-organoid unit.

A unique and outstanding chance for modern drug discovery and development lies in the establishment of equivalents of functionally relevant to ADMET- and immunogenicity testing of human micro-organoids in vitro predictive to human exposure. With such proper in-vitro equivalents, a new quality of efficacy data for drugs and biologics can be envisioned prior to clinical trials.

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