Outlook

In the past, technical systems capable of orchestrating all relevant parameters into functional micro-organoid cultures with balanced homeostasis in vitro seemed to be a dream. However, the various chapters of this book have addressed recent advancements in different research areas which, once they can be synchronized into comprehensive interdisciplinary development programs, will overcome the remaining challenges and hurdles. Moreover, when the dream becomes reality, broad applications in modern drug discovery and testing can be envisioned. Meanwhile, preclinical drug testing seems to be the most important application, and its use in early phases of the drug development time line for predictive drug screening, as well as for post-approval extension or restriction of indication to specific genotypic subpopulations, might be of great value (Fig. 11.2). Finally, properties relating to individuals can be tested for individualized therapies. As discussed earlier, an extension of use to non-pharmaceutical areas such as cosmoceuticals and nutraceuticals can also be envisioned.

The envisioned developments are embedded in a sensitive socio-ethical environment. On the one hand, success in this area will not only replace currently used animal tests - as highlighted in Chapter 10 - but also significantly increase predictiveness. On the other hand, however, there are reasonable doubts of whether - and to what extent - human embryonic cell and tissues might be involved in the development and exploitation of such technologies. We strongly believe that within the next few years, by carefully weighing ethical issues against medical needs, programs will lead to revolutionary new robust and reliable technologies emulating human organ function in vitro. Details of conference programs and activities related to this topic are summarized in Table 11.2, which provides the reader with access to information on the latest developments in this field.

Efficacy testing ADMET Re-evaluation Dedicated genotype for drag selection Immunogenicity of adverse side effects testing for indication expansion or decrease

Fig. 11.2 The potential impact of micro-organoid testing technologies on the drug development timeline. ADMET and immunogenicity testing are the primary targets for newly envisioned micro-organoid drug-testing systems. The use of this technology might also be widened towards efficacy testing in drug discovery and the re-evaluation of drug effects in clinical trials, or after-market approval with regard to genetic predisposition.

Efficacy testing ADMET Re-evaluation Dedicated genotype for drag selection Immunogenicity of adverse side effects testing for indication expansion or decrease

Fig. 11.2 The potential impact of micro-organoid testing technologies on the drug development timeline. ADMET and immunogenicity testing are the primary targets for newly envisioned micro-organoid drug-testing systems. The use of this technology might also be widened towards efficacy testing in drug discovery and the re-evaluation of drug effects in clinical trials, or after-market approval with regard to genetic predisposition.

Conference Organizer Website

1

Tissue Models for Therapeutic Development

Cambridge Healthtech Institute

http://www.healthtech.com

2

Tissue Technologies for Discovery Research

Cambridge Healthtech Institute

http://www.healthtech.com

3

Drug Discovery Technology® & Development

IBC life Sciences

http://www.drugdisc.com/section.asp

4

World Congresses on Alternatives & Animal Use in the life Sciences

Alternatives Congress Trust

http://www.worldcongress .net/

5

Characterization and Comparability for Complex Biological Products

The Williamsburg BioProcessing Foundation

http://www.wilbio.com/

6

Annual Conference of SBS

The Society for Biomolecular Sciences

http://www.sbsonline.org/

7

Systems Biology

International Society for Computational Biology

http://www.iscb.org/events/

8

Annual Meeting of ESACT

European Society for Animal Cell Technology

http://www.esact.org/

9

Congress of the European Society for Artificial Organs

ESAO

http://www.umu.se/phmed/medicin/ESAO/

10

Cell & Gene Therapy Forum

Phacilitate

http://www.phacilitate.co.uk/index.html

11

European Stem Cells & Regenerative Medicine Congress

Terrapinn

http://www.lifescienceworld.com

1 Carrel, A. On the permanent life of tissue outside of the organism. J. Exp. Med. 1912, 15, 516-528.

2 Fell, H. B. and Robison, R. The growth, development and phosphatase activity of embryonic avian femora and limb buds cultivated in vitro. Biochem. J. 1929, 23, 767-784.

3 McLimans, W. F., et al. Kinetics of gas diffusion in mammalian cell culture systems. Biotech Bioeng. 1968, 10, 725-740.

4 Griffith, L. G. and Swartz, M. A. Capturing complex 3D tissue physiology in vitro. Nat. Rev. Mol. Cell Biol. 2006, 7, 211-224.

5 Okazaki, K. M. and Maltepe, E. Oxygen, epigenetics and stem cell fate. Regen. Med. 2006, 1, 71-83.

6 Wilson, A. and Trumpp, A. Bone-marrow haematopoeitic-stem-cell niches. Nat. Rev. Immunol. 2006, 6, 93-106.

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