JUDGING CRITERIA

Submitted Reports will be evaluated based on the following Judging Criteria. Participants are encouraged to review these criteria in detail and tailor their submissions accordingly.

For the interim Phase 2 submissions, judges evaluate the interim reports based on the following criteria:

1. Off-Target Characterization. Extent to which the data and results demonstrate the ability to characterize (monitor, measure, and evaluate) relevant off-target effects outside of the intended autonomic function. Characterization of off-target effects should include appropriate and sufficient controls and statistical analyses.
2. Interim Targeting Performance. Extent to which the data and results demonstrate the necessary requirements for selectively modulating an autonomic function with a high degree of tunability, accuracy, and precision. Controls and statistical analysis of autonomic function modulation should be appropriate and sufficient for determining effect.

For the final Phase 2 submissions, judges evaluate the final reports based on the following four criteria:

1. Off-Target Characterization. Extent to which the data and results demonstrate the ability to characterize (monitor, measure, and evaluate) relevant off-target effects outside of the intended autonomic functions. Characterization of off-target effects should include appropriate and sufficient controls and statistical analyses.
2. Final Targeting Performance. Extent to which the data and results demonstrate the necessary requirements for selectively modulating two or more autonomic functions each with a high degree of tunability, accuracy, and precision. Controls and statistical analysis of autonomic function modulation should be appropriate and sufficient for determining effect.
3. Plans for how to address FDA feedback. Extent and feasibility to which FDA concerns are addressed if applicable (if determined to be non-significant risk, this criterion will not be utilized).
4. Clinical Relevance. Extent to which the results are likely to provide clinically relevant improvement in target function (not just statistical significance) as well as potential comparisons to currently available prescribed treatment for target indication if applicable.
5. Technology Readiness. Do in vivo studies demonstrate the efficacy of the proposed technology in accordance with its intended use? Have biomarker(s), assays, and endpoint(s) been used that can be further used in clinical studies? What is the feasibility of submitting for an FDA IDE or begin a new efficacy clinical trial within 1-2 years (i.e., by the end of a potential phase 3)?

 

Judging Considerations: Judges will be asked to consider the following in their evaluations of the above criteria:  

• Neuromodulation control—Demonstrated ability to control each autonomic function independently, and for any and all target functions identified, how the approach resulted in:
  • Precision of stimulation outcomes within a generally accepted range of variability. How consistently does a given neuromodulation parameter result in similar change in the intended autonomic function (as indicated by biomarker measurement)?
  • Accuracy of stimulation outcomes to a generally accepted standard of error for the target indication(s). How close is the measured result to the intended change in autonomic function (as indicated by biomarker measurement)?
  • Tunability of both the stimulation parameters (e.g., amplitude, pulse width) and resultant change in autonomic function. How finely adjustable is the functional response (as indicated by biomarker measurement) in regard to a change in the stimulation parameter?
• Biomarker Characterization[1]--A quantitative assessment of both on-target and off-target events that occur in response to neuromodulation. Identified biomarkers must include those which are regulated by the same nerve being modulated and be correlated with outcome.

[1] A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or biological responses to an exposure or intervention, including therapeutic interventions. Biomarkers may include molecular, histologic, radiographic, or physiologic characteristics. Source: FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK326791/ Co-published by National Institutes of Health (US), Bethesda (MD).
 
Submissions will be evaluated by a Judging Panel composed of Federal employees from across NIH and potentially other federal government agencies. The Judging Panel will select the interim milestone winners and up to five semifinalists as winners of Phase 2 of this Competition, subject to a final decision by the Award Approving Official. Prior to evaluation by the Judging Panel, submissions may initially be evaluated by individuals of a multidisciplinary Evaluation Panel composed of subject matter experts in relevant areas from across the academic, nonprofit, and/or industry sectors. The Evaluation Panel would not make any selection decisions or collective recommendations but would provide their technical evaluations of individual submissions to the Judging Panel. 

Future phases

Evaluation of submissions in any potential future phases of the Competition is anticipated to include similar criteria to Phase 1and 2 with adjusted expectations for empirical data and results leading up to IDE-enabling studies, advances in the field of neuromodulation research, as well as an increased emphasis on progress made from previous phases and ability to achieve regulatory and commercial success. Additionally, potential future phases may include interim milestone submissions and evaluations, with associated interim monetary awards, in addition to a final submission and evaluation for each phase. As stated previously, any future phases would be launched by way of an announcement that describes requirements and registration, as well as prize amounts. Moreover, announcement of additional phases of this Competition is at the discretion of NIH and contingent upon the availability of appropriated funds from which payment for this purpose can be made. 

Registration & Submission Process:

Participation in Phase 2 is limited to selected winners (quarterfinalists) of Phase 1of the Neuromod Prize. To enter Phase 2 of the Competition, these eligible Participants must go to the Competition website and complete all required fields of the Competition registration form through the Luminary LightboxTM platform on the Competition website before Sept 1, 2023. This includes responding to all required fields of the registration form.

Upon submitting an entry to this Competition, Participants will be required to identify whether they are registering as an Individual (i.e., on behalf of yourself), Team (i.e., on behalf of a group of individuals), or Entity (i.e., on behalf of a legally established organization, institution, or corporation) and acknowledge whether federal funding was used in the development of the Challenge submission. All Participants must certify they have read and understand and agree to abide by the official Eligibility Rules and Participation Rules for the Challenge as stated in this announcement.

• For Individuals: To be eligible to receive a cash prize, the Individual must be a citizen or permanent resident of the United States.
• For Teams (group of individuals): Each participating Team is required to identify a Team Captain who will register and submit on behalf of the Team members. The Team Captain is responsible for all communications with the Challenge sponsors and, in the event of winning a cash prize, will be paid the prize in full. To be eligible to receive a cash prize, the Team Captain must comply with all Eligibility Requirements stated in the Official Rules, Terms, and Conditions, including being a citizen or permanent resident of the United States. In the event that a dispute regarding the identity of the Team Captain who actually submitted the entry cannot be resolved to NIH’s satisfaction, the affected submission will be deemed ineligible. Individuals may participate in more than one Team; however, an individual serving as a Team Captain may only be a Team Captain for one Team in this Competition.  may only
• For Entities: Each participating Entity is required to identify a Point of Contact who will register and submit on behalf of the Entity. The Point of Contact is responsible for all communications with the Challenge sponsors. In the event of winning a cash prize, the prize will be paid directly to the Entity, not to the Point of Contact. To be eligible to receive a cash prize, the Entity must be incorporated in and maintain a primary place of business in the United States. As stated in the Participation Rules, Participants intending to use Federal grant, cooperative agreement, or OT award funds must register for and participate in the Challenge as an Entity on behalf of the awardee institution or organization. In the event that a dispute regarding the identity of the Point of Contact who actually submitted the entry cannot be resolved to NIH’s satisfaction, the affected submission will be deemed ineligible.

The deadline for Interim Phase 2 submissions is 4:59 p.m. EDT on September 1, 2023. The deadline for final Phase 2 submissions is 4:59 p.m. EST on December 1, 2023. We recommend submitting at least one hour before the deadline to ensure your completed submission is received. The submission form is best viewed using Chrome, Firefox, or Internet Explorer 10 or higher. To prevent the loss of any entered information, we recommend saving the form as a draft prior to attaching any files or editing your team contact information. When submitting, please do not reload the form or exit the browser until you see a message confirming we have received your submission. If you encounter any issues, please email hello@neuromodprize.com with a description of the problem, a screenshot, and the date and time of the occurrence.

Submission Requirements

The primary component of a submission will be a report that summarizes your experiments, methods,data, and results. To submit, Participants must complete all the required fields and upload the required document on the Luminary LightboxTM platform via the Competition website.
The submission(s) must provide sufficient description of the experiments, methods, data, and results for the judges to determine whether or not criteria have been met.

Submission Guidelines

Submission details

Each report must include a title page and main body. Supporting information may be included in an appendix (such as FDA response to pre-submission, or Non-significant risk determination) which does not count toward the maximum page limit for each report. The appendix is not guaranteed to receive the same level of review as the main body of the report but may provide helpful context or clarification. Submissions must be submitted as a PDF and formatted with 1-inch margins (2.5 cm), using an easily read font with a minimum 12-point size.

• Interim report should be a maximum of 6 pages.
• Final report should be a maximum of:
  • 15 pages if Non-significant risk determination is made.
  • 18 pages if including a plan to address FDA feedback in response to an investigational device exemption (IDE) Pre-Submission.
• Title Page (not included in page maximum) must include the following:
  • Title of your submission. (15 words maximum)
  • List the team lead and partners
  • Submission category: Indicate whether report is for the interim or final milestones
  • Submission executive summary/abstract: Briefly summarize your report, addressing how it meets the evaluation criteria. (250 words maximum)
    • Note: Please do not include any proprietary or confidential information in the submission title, headline, and executive summary sections as they will be publicly shared for those submissions selected to win a prize.
  • Target functions: List the autonomic function(s) and end organ(s) your neuromodulation solution targets.
  • Off-Target indications: List the function(s), response(s), measure(s) that are likely off-target effects based on the anatomy and functional connectivity of your nerve target and surrounding neuromodulation site.
• Submission main body: description of the rationale, methods, data, and results. Please provide images, graphs, statistical power analysis, summary statistics, etc… as would be expected in a peer reviewed publication.
  • Interim milestone submission:
    • Report (6 pages max) of methods and results demonstrating modulation of a single autonomic function with simultaneous characterization of off-target effects.
  • Final milestones submission:
    • Report (15 pages max) of methods and results demonstrating modulation of multiple autonomic functions with simultaneous characterization of off-target effects. Include the following:
    • Methods 1-2 pages
    • Final Targeting Performance 4-5 pages including:
      • Neuromodulation control: Precision, Accuracy, and Tunability;
      • and Biomarker Characterization
    • Off-Target Characterization 4-5 pages
    • Clinical Relevance 2-3 pages 
    • Technology Readiness 2-3 pages
    • Either:
      • Documentation (appendix) that study was determined to be of Non-significant risk, or
      • Plan (3 pages max) to address FDA feedback in response to an investigational device exemption (IDE) Pre-Submission.