Among the Funding Opportunity Announcements listed in this month’s Research News, there are several that can be leveraged in support of preclinical and/or clinical therapy development for DM.
NINDS has rereleased the CREATE Bio and NIH has rereleased the Blueprint Neurotherapeutics initiatives that support development of biologics and small molecule drugs, respectively. Note that the definition of ‘biologics’ in the NINDS programs differs from that of FDA in including oligonucleotide drugs.
NINDS has reissued their Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases initiative. This initiative is designed to address clinical trial readiness by funding studies to validate clinical outcome measures or biomarkers, or provide needed natural history data through characterization of cohorts of relevant patients.
NINDS has rereleased the NeuroNEXT initiative, to support exploratory clinical trials within the NeuroNEXT infrastructure—including clinical coordinating center and data coordinating center support. Studies “may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies.” Applicants do not have to currently be part of the existing NeuroNEXT network in order to propose studies.
Finally, NINDS has issued initiatives to support analytical and clinical validation of candidate biomarkers for neurological disorders.
Programs focused on DM should be eligible to compete for funding under any of these initiatives. Prospective applicants are strongly encouraged to discuss applications with NIH program staff identified in the Funding Opportunity Announcements.