The Neuronet Working Groups (WGs) are cross-project spaces for experts to discuss common issues, priorities and opportunities for synergy and collaboration, providing Neuronet with expert advice on four identified areas of interest: data sharing, patient privacy & ethics, HTA/regulatory interactions, and sustainability. As such, the WGs make an important contribution to Neuronet’s goal of compiling and leveraging the expert knowledge that is presently scattered across the different neurodegeneration projects in the Innovative Medicines Initiative (IMI) portfolio. During the last month, each of the four Neuronet Working Groups has held an online meeting, bringing together project experts on the areas of interest listed above.
Data Sharing and Reuse
The main aim of the Neuronet “Data sharing and re-use” WG is to develop specific guidance to aid projects on data sharing policies and tools, incentives, value propositions, infrastructural solutions, etc. This WG will develop guidelines aimed at facilitating the sharing of and access to data, biological tools and other materials amongst IMI projects, as well as with other interested researchers at a European and global level. Based on the first TC (held on the 29th of November 2019) and the first face-to-face meeting (held on the 26th of February 2020), the scope of this working group was defined by the experts involved in several IMI projects like EPAD, EHDEN, EMIF-AD, AETIONOMY, etc. The WG meeting was chaired by Lennert Steukers, IMI Neuronet Project Lead and Associate Director Neuroscience at Janssen Pharmaceutica NV.
Patient Privacy and Ethics
The primary goal of the Neuronet Patient Privacy and Ethics WG is to compile and share learnings on patient privacy and ethics, including guidance on ethical standards and practices to ensure personal data is protected. The June WG meeting was attended by ethics and data protection experts working on the EPAD, AMYPAD, RADAR-AD, MOPEAD, EMIF and AETIONOMY projects, among others, and was focused on identifying key topics to be addressed by the WG over the next two years of Neuronet. Potential topics that were discussed include the communication of risk to participants, consent clauses for data reuse, reidentification of participants and public involvement in research. The WG meeting was chaired by Jean Georges, Executive Director of Alzheimer Europe.
Health Technology Assessment (HTA) and Regulatory
The main aim of the Neuronet HTA and Regulatory interaction working group is to generate insights into the regulatory and HTA challenges and opportunities that are unique to neurodegenerative diseases, including developing guidance to support effective engagement with regulators, HTA agencies and payers in the EU. The WG held its second meeting in April which was attended by HTA and regulatory experts working on the ROADMAP, EPAD and AMYPAD projects. The main focus of the meeting was the presentation of a Regulatory and HTA interactions Decision Tool which has been developed to support projects in the portfolio to identify suitable processes and procedures for engagement with regulatory and HTA bodies at different stages of the development of an asset or output. The Decision Tool has been made available as a resource to the IMI ND portfolio through the NEURONET Knowledge Base. The WG gave positive feedback on the tool and discussed ways in which it could be further developed, including developing case studies on the experiences of projects who have gone through a regulatory/HTA process or procedure, and signposting to more detailed published regulatory ND guidance.
The goal of the Neuronet Sustainability WG is to share and compile knowledge and information about the sustainability models used in or applicable to IMI neurodegeneration projects as a resource for current and future projects to improve the chances of successful sustainability decisions. In the last meeting, held on 18 May 2020, sustainability strategies of the projects EQIPD and AETIONOMY were presented and discussed. EPAD, DPUK, EMIF-AD sustainability models had been presented already in previous meetings. Topics discussed include the sustainability advice provided by IMI or EFPIA, the difficulties in finding funding to sustain assets beyond the IMI funded phase and levels of legal and business development knowledge in IMI consortia. The WG meeting was chaired by Carlos Díaz, CEO of Synapse.