Introduction

Each year, approximately 20 to 25 new drugs and biologies are approved by the US Food and Drug Administration (FDA), with a growing share of biologies. In recent years, the development costs of new drugs and biologies have increased dramatically. Currently, drugs and biologics proceed from preclinical development into the market with a probability of success between 2 and 15%, but with total aggregated costs of US$ 500-800 million for each successful market approval achieved. Despite growing regulatory bureaucracy, capabilities on safety and efficacy assessment are the key cost drivers.

During these early years of the 21st century, with the emergence and maturation of the "-omic" technologies (genomics, proteomics, glycomics, lipomics), unprecedented discoveries are ongoing in the fields of system biology. With these accumulated data, for the first time in human history, rational approaches for the discovery, evaluation and development of new medicines might become reality. This will allow for selection of the correct candidates at very early stages in the drug development timeline, thus substantially reducing the failure rate in clinical trials. The lack of reliable drug-testing technologies able to predict the outcome of individual human exposure turned out to be the most prohibitive bottleneck enforcing these rational, risk-benefit-structure, balanced, cost-effective development approaches. Experience during the past decades has shown clearly that neither animal testing - even on our nearest relatives, the chimpanzees - nor conventional culture screening and testing using cell lines, sufficiently emulate the complex behavior in human individuals which is the basis of proper rational drug development.

Recent achievements in stem cell research, human cell engineering, biomaterial sciences, tissue bioreactor design and micro-biosensor developments are crucial prerequisites for the development of novel platform technologies for human micro-organoid in-vitro cultures to overcome these bottlenecks. Despite exciting achievements in each of these areas, predictive procedures for assessing human exposure via drug screening and testing based on such platform technologies remain very rudimentarily available at the research level. The combined efforts of biologists, physicians, engineers and other different disciplines are necessary to derive in-vitro equivalents for the most important human organs and systems for adsorption, distribution, metabolism, excretion, toxicity (ADMET) and efficacy testing on an industrial scale and throughput.

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