To describe the steps taken by the CMSAN team in developing a single state of the art shared CNS inflammatory disorders biorepository.

Biorepositories are key elements in research and can be quite costly and if not properly planned, unsustainable. With rapid growth in technologies applicable to medical research, the future of clinically relevant discoveries is dependent on robust biorepository infrastructure, where samples for well clinically characterized patients are available for analyses.

The major steps undertaken by our group in building our biorepository infrastructure are: 1) Acquisition and allocations of funds to support creation and sustainability; 2) Consent form development –“enrollment of all ages for life”; 3) Institutional Review Board and biospecimens approval including consolidation of individual investigator driven repositories under a single “umbrella” biorepository-allowing access to retrospective collections but providing a single method of collection, available to all investigators, moving forward; 4) Prioritizing disease phenotype (MS, NMO, optic neuritis, autoimmune and paraneoplastic disorders) and number of patients for collection; 5) Data collection- databases and forms created to ensure systematic documentation; 6) Biospecimens- what to collect? RNA, DNA, PBMCs, fibroblasts, serum, plasma, CSF etc.; 7) Processing/storage; 8) Governance and oversight to ensure use of samples aligns with goals;  9) Staffing-enrollment and regulatory.

To-date we succeeded in establishing a well-designed biorepository within our regulations, bylaws, and SOPs, and with a sustainable budget. We have consented 423 participants with a wide range of inflammatory CNS disorders from 45 U.S. states and 5 foreign countries. Sharing of this resource with our members and multiple external academic research institutions has allowed investigation of novel technologies and biomarker discovery and is providing new insights into disease mechanisms.

Understanding the steps required in biorepository development and the financial and regulatory challenges encountered by our Center’s team may assist other investigators considering similar endeavors at other research facilities.