Request for Information: NIH-Industry Partnership towards Clinical Utility of Market-approved Devices to Support New Market Indications within SPARC (Stimulating Peripheral Activity to Relieve Conditions)
Release Date: October 28, 2014
Response Date: November 25, 2014
National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
The National Institutes of Health (NIH) seeks input on a new program, Stimulating Peripheral Activity to Relieve Conditions (http://commonfund.nih.gov/sparc/index), to deliver detailed, integrated functional and anatomical neural circuit maps in multiple organ systems. These maps will be directly leveraged to develop and pilot multiple novel electrode designs, with corresponding stimulation protocols and minimally invasive surgical procedures, to improve existing neuromodulation therapies or pursue new indications. SPARC will provide the scientific foundation required to catalyze the development of new and/or more efficacious therapies utilizing closed-loop neuromodulation to modulate end-organ system function. This will be accomplished primarily by generating detailed functional maps of end-organ systems in appropriate animal models, while validating the relevance of these maps for human translation. The NIH is interested in understanding how cellular and tissue based responses form the underlying mechanisms of neural control networks. SPARC is primarily focused on autonomic nervous system control of, and sensory feedback from, internal organs, but interests may extend beyond these to other organs that show promise for development of neuromodulation therapies.
Pending the availability of funds, SPARC will be implemented starting in FY2015 by the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. The SPARC program is a high-risk, goal-driven endeavor to provide insights into the neural control of organ function, and lay the foundation for the development of neural control devices to precisely treat a wide variety of diseases and conditions.
The NIH seeks input from the biomedical research community, potential biotechnology and pharmaceutical company partners, and other members of the public on this new program. Through the SPARC program, the NIH plans to support interdisciplinary teams of investigators to deliver neural circuit maps of several organ systems, novel electrode designs, minimally invasive surgical procedures, and stimulation protocols. Driven by end goals of improving existing and developing new neuromodulation therapies, the program will be iterative and dynamic, with the novel technologies informing mapping efforts, and the mapping results defining new technology requirements.
Current plans for SPARC include potential initiatives to:
This RFI is intended to gather information and identify interested parties to inform a follow-on workshop. The RFI and workshop may lead to a subsequent funding opportunity announcement; however, this RFI should not be construed as a funding opportunity. Additional information, including future funding announcements for SPARC, can be found at: http://commonfund.nih.gov/sparc/index).
This RFI is focused on the planned initiative, "Exploratory Clinical Studies to Investigate the Use of Existing Market-Approved Technology for Small Market Indications". It invites input from the scientific community, potential industry partners, and other members of the public on all aspects of the program. Small businesses with appropriate technologies are especially encouraged to provide input. Commercial stakeholders are likely to come from a variety of disciplines that include, but are not limited to: Pharmaceutical, biotechnology, and medical device manufactures involved with commercial distribution of cochlear implants, cardiac pacemakers, deep brain stimulators, and other devices that exert a therapeutic effect through direct modulation of neural activity.
Please provide perspectives and pertinent references, as well as names of key experts related to any of the following topics, though your comments are not limited to these topics:
To ensure consideration, responses must be received by November 25, 2014, and must be submitted to SPARC_Small-Market@mail.nih.gov.
Responses to this RFI are voluntary and may be submitted either anonymously or with identifying information. Please do not include any personally identifiable or other information that you do not wish to make public. 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.
This RFI is for informational and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States (US) Government to provide support for any ideas submitted in response to it. Please note that the US Government will not pay for the preparation of any information submitted, or for its use of that information.
1. Birmingham, K., et al., Bioelectronics Medicine: a research roadmap. Nature 13: 399-400, 2014.
Please direct all inquiries to:
Danilo A. Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)