Altex t4 Report 2020: MPS stakeholders are all pulling in the same direction

Berlin, Germany – Back in June 2015, a “CAAT Transatlantic Think Tank on Toxicology (t4)” came together in Berlin for the first time to discuss the capabilities, hurdles and promises of microphysiological systems (MPS). [1] The Center for Alternative to Animal Testing in Europe (CAAT-Europe) situated at the University of Konstanz, Germany, is supporting the 3R’s principle of replacing, reducing and refining animal research, among other things, by hosting various workshops. Organized by Adrian Roth from Roche, Switzerland, Thomas Hartung from the Johns Hopkins University, USA and Uwe Marx from TissUse, Germany, the CAAT workshop brought together all stakeholders in the field of MPS to address the roadblocks on the way to industrial adoption and regulatory FDA/EMA/ICH acceptance. [2] This resulted in the first t4 report on „Biology-Inspired Microphysiological System Approaches to Solve the Prediction Dilemma of Substance Testing“ published in ALTEX in 2016. [1]

Now 4 years later, MPS systems are considered “an enabling technology for the development of approaches to reliably predict the safety and efficacy of novel drug candidates prior to their use in humans.” [3] As a result of a subsequent CAAT workshop organized by the same team 46 representatives of all different stakeholders published a new t4 report on “Biology-inspired Microphysiological Systems to Advance Patient Benefit and Animal Welfare in Drug Development”, in February 2020. Together, the experts analyzed the hurdles that MPS systems have to overcome to be adopted by the pharmaceutical industry and ultimately reach acceptance in regulatory approval processes. On top of that, the report summarizes information about the different systems and assays currently used in industry for internal portfolio decision-making. All stakeholders, involving academia, suppliers, end user industries and regulatory bodies from all over the world were pulling in the same direction of global regulatory acceptance. Now, the recommendations and solutions have to be implemented to impact the replacement of animal models and reduce drug attrition rates in clinical trials by MPS tools in life science research and drug development. [4]

The workshop was accompanied by a public information day on “Biology-inspired Microphysiological Systems (MPS) to advance Medicines for Patients Benefit” hosted at the Centre for Entrepreneurship of the TU Berlin, Germany to be able to include and inform society and politics as well. [3] In the following two days, the 46 experts gathered together to combine their expertise to work on the different topics in 5 groups. Together with Uwe Marx, founder and CEO of TissUse, two of our colleagues, Eva Dehne and Isabell Durieux, attended the workshop. After several rapporteur presentations and discussions, the roadmaps for writing the group’s chapters were set. A dedicated chairman of each working group led the chapter writing process, being supported by feedback from the group members. To finalize the report after alignment of the single parts, all members were asked to go through the report, giving a last round of feedback. The feeling of working together but also dining and laughing together in a team with all the stakeholders, competitors, academia and industry, was described as empowering and a great experience overall. This is an example of how organizations can partner together for international interest and for the scientific community at large. [2]

All participants of the workshop collectively representing the four stakeholders in the field – academia, the MPS supplier industry, the end-user industry (pharmaceutical industry, consumer industry, CROs) and regulatory bodies – are enthusiastic about contributing to the ethical impact on patient benefit and animal welfare in our society along the sketched roadmap. [4]

If you would like to find more collected information on MPS and read why despite their disruptive potential and a more than 15-year history, the current life cycle of MPS-based assays is still in its infancy but about to grow fast, go to https://www.altex.org/index.php/altex/article/view/1526 and browse through the topics of:

• MPS research highlights in academia and MPS-based assay adoption by industry
• Scientific challenges, industrial hurdles and communication gaps for MPS
• Global networking strategies – solving the communication gap
• Qualification of MPS – how to address the major challenge for industrial adoption?
• How to solve the regulatory acceptance dilemma?
• Areas where MPS can win in drug development and beyond
• Recommendations, a roadmap towards and a long-term vision for accepted MPS-based models and assays

At TissUse we dedicate our work to the development of MPS platforms with high quality standards. Our facility has recently been certified under the ISO EN 9001-2015. Now, with our models, it is our ambition to reach the regulatory acceptance first. MPS systems hold the capability to truly emulate human biology and therefore to substantially increase a candidate’s success rate in clinical development (currently at 15 %), which might result in an estimated twofold reduction of development time and fivefold reduction of drug development costs in the future. [1]