Have a proposal to submit to the network?

If you have an idea you would like to develop, the CinciNEXT team is here to guide you through the process.

The NeuroNEXT network is funded by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (NINDS). NeuroNEXT is designed to:

  • Increase efficiency of clinical trials
  • Expand the capability of NINDS to test promising new therapies
  • Respond quickly as opportunities arise to test promising new treatments for people with neurological disorders

The NIH/NINDS also provides specific gene-based therapy research opportunities through NeuroNEXT and the new URGenT Network. 

The URGenT Network (Ultra-rare Gene-based Therapy Network) is an NINDS translational research program, and its priorities are considerably more targeted than NeuroNEXT's. NINDS describes URGenT's central mission as advancing gene-based therapies for serious, life-threatening ultra-rare neurological disorders from late-stage preclinical development into clinical testing.

NeuroNEXT  

NeuroNEXT supports early-phase neuroscience clinical research across a wide range of neurological conditions. Key priorities include: 

  • Phase II exploratory clinical trials  

  • Biomarker and clinical outcome validation  

  • Rare and ultra-rare neurological diseases  

  • Early gene- and transcript-directed therapies  

  • Innovative and efficient clinical trial designs  

  • Rapid implementation of multicenter studies 

URGenT  

URGenT focuses on advancing gene-targeted therapies for rare neurological diseases from the laboratory toward clinical testing. Key priorities include: 

  • Precision and individualized genomic medicine  

  • Viral vector, oligonucleotide, and other gene-targeted therapies  

  • Late-stage preclinical and IND-enabling development  

  • Regulatory preparation  

  • Advancement to first-in-human clinical trials  

An Other Transaction Authority (OTA) is a legally binding instrument used by federal agencies to acquire research and prototypes more quickly and flexibly than through traditional government contracts. OTAs are particularly useful for high-risk, high-reward technology development.

The process typically involves collaboration between the government, industry, and academic partners. Unlike rigid contracts, OTAs allow for more negotiation and modification, enabling agile adaptation as a project evolves. This streamlined mechanism is ideal for fast-paced fields like neurotechnology, where innovation often outpaces standard procurement cycles.

  1. Submit your proposal idea to the CinciNEXT Team. Our team will work with you on your proposal idea and on completing the NeuroNEXT Clinical Study Concept Synopsis form.
  2. Is “The CinciNEXT team will help schedule a preliminary call with the NINDS Program Directors for NeuroNEXT. We will ensure your concept addresses whether or not the project meets the mission and priorities of the Network?
  3. “Our team will help facilitate submission of the Concept Synopsis to the NINDS”
  4. “A suitability survey will be requested by NINDS. The survey is to gauge interest, enthusiasm, and whether the concept addresses an unmet need in the field. The NeuroNEXT Data Coordinating Center (DCC) will distribute the survey to all clinical sites. Results are shared with NINDS.
  5. “If the concept is deemed suitable, NINDS will work with you directly to submit a Stage 1 submission. Once submitted to NINDS, Stage 1 applications are then reviewed internally.
  6. “If an applicant is invited by NINDS to submit a Stage 2 proposal, the proposal is developed in collaboration with the NeuroNEXT Clinical Coordinating Center (CCC) and the DCC, who will set up a Protocol Working Group (PWG) to provide insight and assistance for the final study protocol and proposal, including budget, statistical plans, and advocacy group involvement.”
  7. “The CCC will submit the finalized proposal to the NIH for review and funding.”
  8. Footnote in smaller font, right justified: “Funding decisions are made by NINDS at the recommendation of the National Advisory and Neurological Disorders and Stroke Council. Funding is not guaranteed for Stage 2 submissions.”

Have an Idea?