February 11, 2022
None
National Institute of Neurological Disorders and Stroke (NINDS)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH)
This Request for Information (RFI) is issued by the Institutes and Centers of The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative . We are soliciting input on opportunities to facilitate collaborations between academic/clinical researchers and potential commercial partners, to enhance the development and dissemination of non-invasive brain imaging technologies. Input is requested from stakeholders such as academic investigators and industry representatives, and the general public.
BRAIN Initiative Overview
Since 2014, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative has aimed to accelerate the development and application of innovative neurotechnologies, enabling researchers to produce a new dynamic picture of the brain that reveals how individual cells and complex neural circuits interact in both time and space. It is expected that these advances will ultimately lead to new ways to treat and prevent brain disorders.
As one of several federal agencies involved in the BRAIN Initiative, NIH's contributions to the BRAIN initiative were initially guided by "BRAIN 2025: A Scientific Vision," a strategic plan that detailed seven high-priority research areas. This plan was updated and enhanced in 2019 by: "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" and "The BRAIN Initiative and Neuroethics: Enabling and Enhancing Neuroscience Advances for Society. This Notice was issued as part of the BRAIN Initiative based on careful consideration by the NIH of the recommendations of these two reports with input from Advisory Councils of the 10 NIH Institutes and Centers supporting the BRAIN Initiative, as assisted by the NIH BRAIN Multi-Council Working Group and Neuroethics Working Group.
NIH BRAIN Initiative Investments in Non-Invasive Brain Imaging Technologies
Starting in fiscal year 2014, the NIH released the following FOAs for the development of next generation non-invasive brain imaging technologies:
- Planning Grants (R24, 3 years): RFA-MH-14-217, RFA-MH-15-200
- Proof-of-Concept Testing (R01, 2 years): RFA-EB-17-001, RFA-EB-17-003, RFA-EB-19-001, RFA-EB-20-001
- Full Scale Development (U01, 5 years): RFA-EB-17-002, RFA-EB-17-004, RFA-EB-19-002
Together, these projects represent a diverse portfolio of next generation imaging modalities at different stages of development aimed at achieving goals of increased sensitivity and spatiotemporal resolution, increased portability and compatibility with complex behaviors, and reduced cost. In its recent report, the BRAIN 2.0 ACD Working Group noted that these grants are scheduled to complete final design, construction and testing over the next few years, and although NIH has made significant progress towards the original BRAIN 2025 goals, success awaits full implementation.
Non-Invasive Brain Imaging Technology Development and Dissemination
In February and March 2021, the NIH BRAIN Initiative held separate workshops on Dissemination of BRAIN Non-Invasive Imaging Technologies and Transformative Non-Invasive Imaging Technologies. The first workshop featured progress updates from BRAIN Initiative U01 awardees, as well as presentations from industry representatives on potential pathways for follow-on dissemination of these specific imaging modalities. The second workshop featured neuroscientists, technology developers/engineers, and industry partners, who are focused on emerging non-invasive imaging technologies that can be realized in the next five to ten years. The discussion centered on ideas for maximizing their potential impact, and identification of possible pathways for their dissemination. Both workshops suggested multiple junctures where projects may benefit from collaborative interactions between investigators and commercial entities. Such opportunities may include further development of nascent ideas, or conversion of first-in-human prototypes into robust, marketable products suitable for broad adoption.
Both the development and dissemination of non-invasive brain imaging technologies present challenges for which the medical imaging industry and its representatives offer deep, and often unique, expertise and experience. These challenges include the requisite scale of manufacturing, complexity of regulatory compliance requirements, and the importance of integrating new technologies into existing commercial platforms to ensure broad adoption. Such considerations may not be thoroughly served by existing NIH funding mechanisms, including those listed above, as well as BRAIN Initiative announcements for small businesses (NOT-MH-21-125) and for dissemination of technologies (RFA-NS-19-006, NOT-NS-21-014). They may, however, benefit from direct engagement between NIH and commercial partners. For example, in 2015 the BRAIN Initiative launched a formal Public-Private Partnership (PPP) Program to engage the invasive brain neuromodulation device industry, with a goal of facilitating research into new targets for brain stimulation and recording. Through this program, NIH provides a central source of information on devices and access to expertise offered by commercial participants, and provides template Collaborative Research Agreement and Confidential Disclosure Agreement documents, to reduce the time needed for negotiations of issues such as intellectual property between medical research institutions and industry The NIH is interested in further understanding the potential utility of an effort to facilitate collaborations between technology developers, neuroscience researchers, and industry partners for non-invasive brain imaging. More specifically, we seek information regarding strategies, potential roadblocks, and solutions that may be considered to enhance the feasibility, speed, and breadth of non-invasive brain imaging technology development and dissemination.
Information Requested
The NIH seeks input from extramural community stakeholders, including academic and clinical researchers, industry representatives, scientific societies and advocacy organizations, federal agencies, as well as from interested member of the public, on collaborative strategies and approaches to facilitate investigator/industry collaborations for development and dissemination of non-invasive brain imaging technologies. Input sought includes, but is not limited to, the following:
- Potential benefits the non-invasive imaging field may realize from collaboration between academic and/or clinical investigators and industry; what collaborative opportunities exist.
- Potential barriers to such opportunities that NIH could serve to mitigate.
- The ways in which the NIH might facilitate collaborations between academic/clinical institutions and industry.
- The stage of the technology development/optimization/dissemination pathway at which opportunities for collaborations between industry and academic/clinical institutions will be most realistic and beneficial. To what extent considerations of research vs. clinical markets affect the collaboration strategy.
- Lessons learned from prior experiences with such collaborations; what was and was not successful and why. The aspects you would do differently now.
How to Submit a Response
You may respond to this RFI by filling out this web form or submitting an email to [email protected] by May 14, 2022. If submitting by email, please include the Notice number (NOT-NS-22-044) in the subject line. Responding to this RFI is voluntary. Responses may address any or all aspects of the information requested or other relevant topics pertinent for consideration by NIH. NIH staff will use discretion when considering responses submitted after the comment period has closed.
Respondents will not receive individualized feedback concerning their responses. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government reserves the right to use non-proprietary technical information in any resultant solicitation(s), summaries, or other materials.
This RFI is for information and planning purposes only and should not be construed as a policy, solicitation for applications, or an obligation on the part of the Federal Government, the National Institutes of Health, or the BRAIN Initiative Institutes and Centers to provide support for any ideas identified in response to it. Please note that 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.
Shumin Wang, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-594-9001
Email: [email protected]
Kari R Ashmont, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: [email protected]
and Human Services (HHS)
