Development of the European OoC Roadmap
During the ORCHID project two workshops were held with experts from academia, pharmaceutical and cosmetic industry, patient organizations, ethics school, biotech companies and regulatory agencies. The bibliographical, bibliometric and market analyses and expert interviews, combined with the outcome of the workshops, identified current unmet needs, key challenges, barriers and perspectives of this technology as basis for developing the OoC roadmap. Six specific building blocks for the roadmap were defined, including priorities, methods and targets for each block. EUROoCS will initiate and catalyse the dialogue between developers, end users and regulators during roadmap implementation.
European Organ-on-Chip Society (EUROoCS)
An outcome of ORCHID in 2018 is the establishment of EUROoCS (www.euroocs.eu) as an international independent not-for-profit organization aiming to encourage and develop OoC research, and to provide opportunities to share and advance knowledge and expertise in the field towards a better health for all. EUROoCS will stimulate dissemination and provide a platform for dialogue and interaction between all parties involved in the OoC field. With the support of EUROoCS the OoC community will be built further in order to accelerate adoption of the OoC technology.
Societal and economic impact-training-education
A budget impact analysis of OoC technology was performed over a 5 yr period. Relative change in costs was assessed through a survey among 17 experts, based on an R&D productivity framework that considered each phase of the drug development process and corresponding main cost drivers. A reduction in total R&D costs of up to 26%, is expected through OoC technology. Savings were achieved by improving the success rates and most benefits were expected in lead optimization and preclinical phases.
The current and future business models and their strengths and weaknesses have been identified. Novel, additional customer market segments, including veterinary industry, military, and chemical industry, allow the development of new business cases and models for OoC technology, thus extending the impact of the technology beyond the scope of drug discovery & development.
The training needs for promoting the development, utility, adoption and qualification of OoC systems have been identified using an online stakeholder questionnaire. The main target populations in need of training are technicians and end-users in both industry and academia, and early career researchers, including those in applied science studies.
Eco-system development and digital platform
A digital platform has been developed within ORCHID that has been integrated in the EUROoCS website. This website stimulates exchange and collaboration between academic and industrial partners or other stakeholders including regulators and patient associations. The digital platform is a reserved area for EUROoCS members, and provides up detailed information, including experts’ contacts, project descriptions and forum discussions. Aim is to encourage researchers and others to become a member and to join the community.
Regulation, Standardization and ethics
For standardization, regulation and ethics a landscape analysis was performed based on scientific and business sources, followed by a SWOT analysis with respect to the development of an innovation roadmap. Today no OoC systems are used in any regulatory approval path, there are no golden standards defined and the ethics impact of a personal OoC model is still largely unaddressed. Several primers and guidelines have been developed addressing ethical aspects in research, regulatory issues and standardization (whitepaper) for reaching out to policymakers, researchers and the public at large, and to align the debate about these topics with the technological advances.
Dissemination and communication
The ORCHID logo, website, brochure and LinkedIn group were created, and ORCHID was presented to the scientific community and companies during conferences and workshops worldwide. The Vision workshop and Strategy workshop have delivered two brochures about the European OoC roadmap that were disseminated to over 2000 people, mostly researchers. Dissemination to the general public was achieved by Twitter or during global events and special meetings with children and high school students, the next generation of OoC researchers. The final report on dissemination and communication contains the future roadmap for outreach activities, that will be covered by EUROoCS.
