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)
Notice Number:
NOT-RM-14-015
Key Dates
Release Date: October 28, 2014
Response Date: November 25, 2014
Related Announcements
Issued by
National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
Purpose
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:
- Deliver detailed, integrated functional/anatomical neural circuit maps in multiple organs or organ systems for understanding the underlying mechanisms of control; develop/pilot novel electrode designs, surgical procedures, and stimulation protocols leveraging insights from the functional maps (see NOT-RM-14-016 for details)
- Develop next-generation technology for stimulating and recording of visceral nerves and tissues, e.g., optogenetics, stimulating/recording electrodes, cell-type specific tracing (see NOT-RM-14-017 for details)
- Partner with industry and FDA to explore utility of existing, approved devices to address new, small-market indications (subject of this current RFI)
- Assemble data from all SPARC initiatives into a coordinated data resource, develop user-friendly computational tools, and incorporate new computer modeling methods
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).
Information Requested
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:
- Extent of potential industry contribution, which could include a supply of low-cost devices and technical support, access to pre-clinical data, cost-sharing, and construction and maintenance of publically accessible data repositories
- New and/or ongoing challenges and opportunities for conducting clinical research utilizing neuromodulatory devices (either pre-market approval, or using expanded research platforms for existing market approved devices)
- Special or unique barriers towards new clinical utility, such as reimbursements and sustained business model
- Resources that a stakeholder company might contribute to the SPARC program in addition to those listed above. Please comment on the type of information about the commercial product that would be disclosed publicly
- Opportunities and concerns for utilizing a public/private partnership structure including intellectual property, and common data standards for access and annotation
- Views of potential academic and industry partners on the transaction cost of developing individual agreements as well as the desirability of using template agreements and incorporating them into this program. NIH understands that a significant impediment to government, academic, non-profit, and industry partnerships involved in discovering and commercializing new uses of devices is the "transaction cost" of negotiating appropriate legal agreements on a case-by-case basis. Thus, to address this concern, a key feature of the program is that template agreements, such as Memorandum of Understanding (MOU), Collaborative Research Agreement (CRA), Confidential Disclosure Agreement (CDA), will be offered as a means of implementing the partnership. We are interested in the views of potential academic and industry partners on the transaction cost of developing individual agreements as well as the desirability of using template agreements and incorporating them into this program
- Whether the goals and incentives of the SPARC program are sufficient for commercial stakeholders to participate in the program
- The type of device one needs access to in order to obtain a mechanistic understanding of neural inputs that modulate organ function
- Additional sources of data that could be obtained to supplement the limited opportunities available to utilize invasive recording/stimulating devices to maximize the value of these studies for the wider community
- Opportunities to enable reverse translation studies as well to validate and optimize animal models
- Resources that a commercial stakeholder might realistically contribute to the SPARC program in addition to the device and the associated data
- The overall stage of product development including the current status of preclinical and efficacy studies. Some stakeholders, in particular Small Businesses, may have a relevant device that has been used to acquire substantial preclinical data and is ready for translation to use in the clinic in the near future
- Other collaboration opportunities and/or business models between NIH and potential commercial partners
- Use/modification of existing neural prosthesis and neuromodulation technology (e.g., cochlear implant, retinal prosthesis, Deep Brain Stimulation) for other end-organ systems
- Data collection, curation, integration and analysis, in addition to capabilities necessary for data sharing of neuroanatomy and neuromodulation of organ function across the research and technology groups, as well as with the public
How to Submit a Response
To ensure consideration, responses must be received by November 25, 2014, and must be submitted to [email protected].
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.
Reference:
1. Birmingham, K., et al., Bioelectronics Medicine: a research roadmap. Nature 13: 399-400, 2014.
Inquiries
Please direct all inquiries to:
Danilo A. Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8064
Email: [email protected]
and Human Services (HHS)
