A primer on organ-on-chip – Desirable, safe & efficient
A deeper analysis of current customer segments, individual customers and the stakeholders within the customer businesses will be performed. One aim of this task is the development of stakeholder profiles across different established B2B customers and customer segments. Organ-on-chip systems are new cutting edge technologies currently designed for customers in the pharmaceutical industry. A second aim of this task is to look beyond the pharmaceutical industry to identify new markets that may have not been concerned by the scientists developing the technology. New markets will be explored using brainstorming and idea creation techniques such as opportunity redefinition, semantic intuition, forced relationships and brainwriting. In this way we may find completely new uses for the organ-on-chip technology that addresses unforeseen markets.
Report on organ-on-chip as next drug discovery route
This working group will identify business models and cases that are currently employed and discuss future alternatives for the commercialization of organ-on-a-chip technology. In a first step, an inventory of business models of commercial organ-on-a-chip providers will be made providing an overview of the current situation. Together with relevant stakeholders, these models will be categorized and evaluated in terms of strength and weaknesses. New business models will be developed using the “lean start-up” methodology and business model canvas.
Propose guidelines for research and use of organ-on-chip technology addressing stakeholders adequately.
Assess regulatory pathways used today, either on purpose or due to the lack of specific regulation. Identify best practises for the use and acceptance of processes, protocols, and supporting technology but in particularly explore shortcomings due to incompatibility and lack of standardisation. Chart the ethical discussion on organ-on-chip technology and areas that may be strongly affected by it (e.g. 3R). All assessments will explore the landscape in the partners’ countries, in Europe, and outside Europe (including US but also assessing trends e.g. in emerging economies).
This task will give insight how to direct the development of organ-on-chip technology towards maximal societal and economic impact. This task will: • Use early Health Technology Assessment to estimate the quantitative economic and societal impact of organ-on-chip technology for targeted drug development. • Perform literature studies and an extensive series of interviews with key-opinion leaders to identify the key issues and relevant criteria of success for organ-on-chip technologies (with WP2), thereby addressing the barriers and ethical and juridical boundaries (with WP2 and WP5). • Use Multi-Criteria Decision Analysis (MCDA) to incorporate stakeholder views resulting in scenario’s for the further development of the organ-on-chip technology, and identify the most promising applications for organ-on-chip technology as well as the benefits of this prioritization (with WP2)
Organize a Strategy workshop gathering the experts, stakeholders, regulators and policy makers, including the members of the advisory board, to build up the ecosystem further (with WP4), and to define the strategy (policy, activities, priorities and timelines) required to reach the goals.
Final dissemination plan for the scientific & industrial communities, and general public
Organize a Vision workshop (invitational, 25-50 participants, including the ORCHID advisory board) to define by consensus the desired and feasible short-term, mid-term and long-term goals and challenges of the roadmap taking into account the state-of-the-art, unmet needs, economic and societal impact (WP3). This will be based on scenario analysis in close dialogue with WP3
In this cross-technology area, standardisation is considered an innovation enabler and accelerator. Identify shortcomings that hamper emerging business models and fast uptake of processes and technologies. This addresses both process/business and technology innovation. Investigate which standardisation approaches and existing standardisation efforts (eventually existing or underway in neighbouring fields) can address shortcomings. Examples are as varied as microfluidic interfacing standards, pilot line fabrication value chains, big data-assisted and remote quality monitoring, etc.). Attention will be given to standardization of work flows (reproducibility, efficiency/automation, etc.), technology platforms and interfaces (modularity, compatibility, level of reuse) and quality/safety assessments. Discussions with organizations active in standardization and industry clusters will be sought (e.g. IEEE, VDE, etc.).
Identify regulatory pathways for different applications and processes of organ-on-chip technology based on existing and novel routes. Identify gaps and shortcomings of existing regulatory processes, together with regulators (e.g. EMA, FDA, national authorities), e.g. in a round table format. Consider regulation at the European level but also include regulation outside Europe and practise in neighbouring/related sectors and applications. Define joint exemplary cases for organ-on-chip -based product innovation trajectories with best practises and suggest actions for regulatory improvements.
Shifting assays from traditional cell culture or animal experiments to bioengineered advanced organ-on-a-chip systems will also change the type of work performed by the responsible researchers. This working group will identify interdisciplinary skills and experiences necessary to prepare young scientists for the utilization of organ-on-a-chip technologies in their future employments. T3.3.1 This task will involve the setting of evaluation criteria for the training taking into account the respective relative importance of skills and expertise. The developed questionnaire will be used for individual and collective stakeholder consultations. T3.3.2 Collective stakeholder’s consultations will be organized in each participating sector and country. All Consortium members who are in close contact to end-users and technology developers will organize stakeholders’ consultations. These consultation events can stand alone or be additional to other events where numerous stakeholders are present (with WP2). The questionnaires resulting from T3.3.1 will be completed. T3.3.3 If procurable, additional experiences from a Marie-Curie Innovative Training Network on organs-on-a-chip, applied for in the H2020-MSCA-ITN-2017 call and coordinated by the FhI-IGB, will be used as further input.
• Develop a draft of the roadmap and conduct one review with roadmap contributors and one external review before finalizing it. • Launch the final roadmap and create awareness in the ecosystem as a first step towards its implementation (with WP6).
Identify risks and opportunities of potential applications enabled by the research roadmap. Reveal stakeholder opinions (individual vs society, citizen vs patient, healthcare system, government, business, science) through literature study, expert consultations and workshops with different stakeholders (with WP2). Categorize ethical implications.
Overall results on the three pillars of regulation, standardisation and ethics will be consolidated and presented in three formats.
Wesite and project logo (will be continuously updated).
The development of the digital platform will be a software coding activity consisting of developing all functionalities defined previously including user authentication, set-up of the search engine for data accessing, the user interface, etc. The digital platform will allow the search of data such as the European patents (patents of the European Patent Office), Scientific articles in Open Access (i.e. scientific articles accessible free of charge and not property of a publisher) and research. All information will be searchable with advanced semantic search tools, used by users through a simple mask for simple queries or through advanced research. The digital platform will enable users to qualify contents retrieved during their researches and considered relevant for the project purposes, through a set of TAGS/Categories previously defined by the project partners. This will allow the community to build steadily a solid knowledge base of clustered contents really relevant for the community, but also facilitate the users’ research activities. Moreover the digital platform will contain a Document Management System (DMS) to manage documents created by the community members. Queries for documents can be performed by keywords and also with the application of additional filters (advanced search, based on file name, file content or tags assigned to the document, is also possible). It will be possible to filter the results using facets (grouping of the results in dynamic categories), based on the tags assigned to the document and on the document creation date. Maintenance and fine tuning of the digital platform will be performed during the project duration.
Author(s): Massimo Mastrangeli
Published in: ALTEX, 2019, Page(s) 481-492, ISSN 1868-596X
Author(s): Nora Franzen, Wim H. van Harten, Valesca P. Retèl, Peter Loskill, Janny van den Eijnden-van Raaij, Maarten IJzerman
Published in: Drug Discovery Today, 24/9, 2019, Page(s) 1720-1724, ISSN 1359-6446
Publisher: Elsevier BV
Author(s): Massimo Mastrangeli, Sylvie Millet, Janny van den Eijnden-van Raaij
Published in: ALTEX, 2019, Page(s) 650-668, ISSN 1868-596X