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Issued by

Office of Strategic Coordination (Common Fund)

Purpose

Phase one (2015-2021) of the Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) program drew many of its goals from a 2013 workshop and follow-on research roadmap published in 2014 (Birmingham et al. (2014) Bioelectronic medicines: a research roadmap. Nat Rev Drug Disc 13:399-400). At that time. several critical priority areas were suggested for research investment, including:

• • Biological maps of structure and function in the peripheral nervous system
  • Advancement of neural interface technology
  • Early establishment of therapeutic feasibility
  • Collaborative data mining and standards
    

Since that time, rapid and wide-ranging progress has been made across these priority areas, supported by NIH SPARC, DARPA ElectRx, and other public and private entities. Novel neuroanatomical techniques have been deployed across the autonomic nervous system; comparisons of species differences have confirmed the importance of using large animal models in device development; therapeutic strategies have begun to target specific afferent or efferent projections; proof-of-concept studies exploring new applications and state-of-the-art modalities of neurostimulation appear on a monthly basis; data annotation for FAIRness is, while not yet mainstream, becoming more accepted as a best practice in the conduct of biomedical research.

The SPARC Working Group is now seeking strategic input from potential partners and other subject matter experts on high-impact collaborative goals that could build on this progress to enable new therapeutic neuromodulation approaches for specific diseases and conditions. To help us to prioritize and gauge collaborative interest in potential high-impact challenge goals, please provide your input by responding to either or both of the following prompts:

Prompt 1

Please suggest one or more high-impact goals for advancing bioelectronic medicine with a scope appropriate to a collaborative effort between government, industry, and/or academic partners.

For each suggested goal, respondents may wish to address the following questions:

• How would achieving the goal define a new neuromodulation target for a disease or condition that currently lacks an adequate therapeutic approach?

• What type of support (funding, regulatory, scientific) would be needed from each partner to achieve the goal within the next 4 years?

• How could the effort leverage the data, maps, or tools created in Phase one of the SPARC program?
• How would this goal attract interest and participation from translationally-minded scientists, engineers, and clinicians across public and private sectors?

Prompt 2

With respect to advancement of bioelectronic medicine on a 5-10 year time horizon, what are the most and least valuable functionalities provided by currently supported central data and knowledge resources?

Respondents may wish to consider the following:

NIH and other public and private entities have funded the development of numerous central data and knowledge resources, for example: SPARC Portal (including data, maps, and simulations), WikiStim, NITRC, Allen Brain Atlas, and BRAIN initiative-supported data archives such as DABI, NeMO, OpenNeuro, DANDI, bossDB, and the Confocal Fluorescence Microscopy Brain Data Archive. These resources variously combine one or more of the following functionalities:

• Data repositories
• Knowledgebases
• Anatomical maps or atlases

• Markup languages and other ontological efforts
• Interoperable computational models
• Cloud storage and computation

• Annotation standards
• Citation practices

With respect to the above list of functions,

• Where is more effort needed? Where is less effort needed?
• Could the development of bioelectronic medicines be accelerated more efficiently by something entirely different?
• In what specific ways does therapeutic development benefit from data sharing and standardized data structuring/annotation by basic researchers?
• The SPARC map-sharing goals have assumed that a public-private partnership model that has been successful in the pharma space, in which public funding identifies targets, and private funding refines and engages them, can be exported to the neuromodulation/bioelectronic medicines space. In what way is this assumption consistent or inconsistent with your experience?

General information:

Responses to this RFI are voluntary and may be submitted either anonymously or with identifying information. Proprietary, classified, confidential or sensitive information should not be included in your response. Comments may be compiled for discussion and may appear in related reports. Any personal identifiers (names, e-mail addresses, etc.) will be removed when responses are compiled. Processed, anonymized results will be shared internally with NIH staff members and any member of scientific working groups convened by the SPARC program, as appropriate.

If contact information is provided, NIH Program staff may contact respondents and may invite some respondents to present concepts for discussion at an ideation summit or other workshop. There will be no obligation to do so, and responses will otherwise be considered confidential.

This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government. The NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information. Additional information, including future SPARC funding announcements, can be found at: https://commonfund.nih.gov/sparc/awards.

To ensure that your input is considered, please respond by October 15^th, 2020. Responses may be submitted by email to [email protected]. Brief responses are welcome on Twitter using the hashtag #NIH_SPARC.

Inquiries

Please direct all inquiries to:

Sidd Shenoy, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Tyler Best, Ph.D.
Office of the Director
Email: [email protected]