Science Advisory Board (SAB) which is appointed and steered by the project’s General Assembly, consisting of a panel of 6 external experts from different academic disciplines/institutional types (e.g. academic, industrial, policy, patient organisations) who between them are qualified in all of the subject areas included within the BIND proposal. They meet twice a year, to ascertain that the work is progressing according to both the scientific plan and time scale and assist and facilitate decisions made by the General Assembly and attend General Assembly meetings if required.
The Dissemination and Exploitation Board (DEB) consists of one representative of all partners and is jointly led by the parent organisation partners UPPMD and DDF (dissemination) and UCL’s Division of Research and Innovation, GOSH, Biomedical Research Centre (exploitation). DEB liaises with the other partners, European patient advocacy groups and TREAT-NMD Alliance Secretariat to disseminate the BIND project results to the patient and science communities and general public. As part of the exploitation plan, UCL, assisted by UPPMD and all clinical partners, takes a lead role in outreach research clustering activities. The DEB reports the dissemination and exploitation activities so that pathways are established for Innovation Management. The exploitation plan provides a framework for the Consortium to identify the inventors of new IP and mechanisms of reimbursement if IP is commercially exploited.
Intellectual Property Committee (IPC) comprises the relevant IP experts from each partner organisation and the Project Coordinator. The IPC is chaired by UCL’s Innovation and Development Manager. The IPC will establish the background IP of each partner at the beginning of the project, by liaising with the relevant IP experts from the partner technological transfer offices and the Project Coordinator. Partners will subsequently highlight foreground IP and any commercially valuable knowledge arising, reporting back to the Dissemination and Exploitation Board (DEB) and IPC periodically for advice on how the new IP should be developed and/or protected. If protection is required, it is addressed before there is any public disclosure of the results or information pertaining to the new IP.
Ethics Board (ETB): oversees both the preclinical and clinical work, monitors BIND’s work and advises on ethical compliance with the relevant national and international regulations where relevant, which are likely to be partner- and or country-specific. The ETB reviews and only provides recommendations a) animal experiments to assess the deep phenotype of the different DMD mouse models and the correlation with dystrophin expression; and dystrophin restoration experiments; b) pathological studies using human biobanked material; c) the deep functional phenotyping of patients ensuring all patient information and consent forms meet the ethical guidelines for their country, and to be harmonisation between the partners, taking into account this individual country variation. The ETB is made up of members of the clinical team, members affiliated to DMD patient charities (UPPMD and affiliated charities) and includes independent assessors qualified in this area.
Data, Safety & Monitoring Board (DSMB) monitors patient safety to oversee the running of the clinical research. The DSMB reports to the Ethics Board (ETB) and Scientific Advisory Board (SAB). The DSMB is made up of members independent of the consortium and monitors Consortium’s relevant activities, such as:
- The collection of clinical data from patients recruited into this natural history study at individual sites.
- The holding of patient data in secure locations within the hospital facilities of each participating institution.
- The collection of data according to GCP rules and to the most recent GDPR compliant regulation, with attention to privacy and data protection and according to the relevant national laws and regulations.
- The notification of National relevant bodies on the data intended to be collected ahead of the study recruitment.
- The information concerning patient’s baseline characteristics, inclusion and exclusion criteria, study endpoints, and adverse events to be collected in a blinded way and coded to protect ensure patient anonymity and privacy.
- The compliance with all EMA standards for electronic data capturing.
- The sharing of only aggregated data with consortium participants and if required.