Digital End-to-End Data Map in Translational Research and the Medical Industry

Practical example and current challenges

• The use of laboratory animals is currently indispensable for experimental medical research, for drug approval and for the re-evaluation of already approved drugs. In this context, the monitoring of the husbandry and the stress associated with the experiments is required by the Animal Protection Act. According to the current situation, the monitoring consists of a punctual visit of the animals and a data recording or observation. During the active time (e.g. at night in the case of nocturnal animals) there is currently no data recording. The visit consists of visual observation and determination of the animal's condition, as well as documentation of the determined data. The records made are the basis for the requirements set out in the Animal Welfare Act and for the analysis of the respective series of experiments. The data, which are mostly collected by hand, remain in the respective institution as a closed system.
• Due to the high influence of animal welfare the experiments and their results, a minimally invasive, remotely available solution adapted to the animal's natural day-night rhythm is necessary. An accurate and detailed understanding of an experimental animal's response and behavior within a series of experiments can, for example, lead to better detection of side effects of tested drugs. This can be ensured by seamless, continuous monitoring of the test animal. Also, strain-specific behavior can be detected, monitored, and better assessed.
• The use case describes the development of an end-to-end system, for sharing and management of animal data, which connects authorities, research institutions and animal welfare in an integrated manner. It includes the implementation of adaptive algorithms for automatic and digital monitoring and recording of measurement data in laboratory animal husbandry. The areas in which this system will be integrated are in translational biomedical research, behavioral research, and research-based pharmaceutical companies. The solution, as well as possible associated alarm systems, will bring a significant gain in knowledge and safety for the research landscape.
• The technical solutions currently available do not provide the basic framework required to implement the use case. For this reason, the initial focus is on developing the necessary infrastructure. This is required for the structured and target-oriented processing of the data that will be generated in the future. In addition, algorithms will be developed and implemented with the aim of enabling an interdisciplinary exchange of data in the field of translational and biomedical research. The added value of this holistic approach is visible in the support of the individual user as well as in the entirety of companies active in the healthcare sector.

What added value does the "Gaia-X project" offer?

• Gaia-X offers the possibility to drive digitization in research institutions and to implement end-to-end digital processes free of media discontinuity, as the sovereign exchange of data across multiple stakeholders is enabled on the basis of Gaia-X. In addition, Gaia-X can bundle artificial intelligence projects in the medical and livestock sectors from companies and research institutions. Gaia-X accelerates these activities by enabling sovereign access to and the distribution of the relevant data.
• Advanced Smart Services are created based on recorded raw data, e.g. different experiments are stored in Data Lakes with different mouse lines. These can then be made available to different, registered target groups in the future. (Today, only 5-10% of the collected data is published. The unused data today is often stored in analog and not shared/used). This creates a new market and animal testing can be significantly reduced, because experiments that have already been conducted would not have to be repeated.
• The approach described maps a transparent digital process. This will "disruptively" accelerate and revolutionize the research and development landscape in all directions. Gaia-X can provide interdisciplinary exchange and the necessary transparency for all participants.
• Gaia-X meets the requirements to provide the basic infrastructure of the use case. The open-source approach brings transparency to a previously closed market. The developments resulting from the implementation of the use case will benefit all participants through the continuous development and improvement approach.
• Gaia-X enables standardization, modularity and scalability of the selected hardware. It also increases transparency and trust in a closed market and enhances animal welfare.

Use Case Team

• Mirko Lampe – IIoT Guidance GmbH
• Dr. Janine Kah – IIot Projects GmbH