About the Digital Biomarker Pilot Program#

Events#

Pitch Competition for the NACC & Gates Ventures AD/ADRD Digital Pilot Program!

Informational Webinar on the NACC & Gates Ventures AD/ADRD Digital Biomarker Pilot Program - January 22, 2024

View Slides Here

The webinar featured an overview of the new program launched by NACC and Gates Ventures and the value that this data will have on AD/ADRD research and innovation! Our speakers Niranjan Bose, PhD of Gates Ventures, Nina Silverberg, PhD of NIA, Rhoda Au, PhD, MBA of Boston University, and Sarah Biber, PhD of NACC covered highly relevant topics such as how to connect with industry partners from an academic lens and why the ADRC Program is a good testbed for developing impactful digital biomarkers. This webinar wrapped up with a Q&A panel - which has been included in the FAQ section.

Application Review#

How to Apply#

Proposal Body Details#

The Proposal Body should include the following six sections:

• Project overview (1 page limit)

  Provide a brief overview of the pilot proposal. Describe what problem this proposed technology will solve. Describe how this proposal will meet the criteria of expanding the collection of richer data with less burden for participants and ADRC staff.

• Project description (6 page limit)

  The project description is the central part of the proposal and should contain the eight sub-sections listed below (indicate each sub-section by number in the proposal).

  1. Background and Rationale

     1. Provide the biological rationale that links the candidate digital measure(s) to disease pathophysiology.
     2. Provide the biological rationale that links the candidate biomarker(s) to disease pathophysiology.
     3. Discuss the novelty of the proposed approach and its leading context of use (CoU).
     4. It is recommended to focus on one CoU, however, if multiple CoU are proposed, please describe additional biomarker categories here and ensure study design will support these additional categories.

  2. Supporting Data

     1. Provide relevant supporting data.
     2. Include data that demonstrates how the candidate biomarker(s) is connected to the disease process.
     3. Provide data for the analytical method such as sensitivity, specificity, accuracy, parallelism, precision, sample stability, and other characteristics

  3. Project Plan and Objectives

     1. Objectives: List specific aims and milestones with clearly defined go/no-go decision points for advancement of the project.
     2. Timeline: Use the Alzheimer’s Disease Drug Discovery Diagnostic Accelerator Project Plan Template (.xlsx) to provide a schedule for the completion of the proposed milestones/deliverables for each quarter of the year for each year of funding.
     3. Discuss critical next steps and/or experiments needed to advance the program to attract additional funding/licensing.
     4. Outline strategies for commercial scale-up, manufacturing, possible cross-platform compatibility, and regulatory approval, including the timeline for FDA submissions and milestones.

  4. Experimental Design and Methods

     1. Describe sample collection methods, storage, stability, and extraction procedures.
     2. Provide details for each analytical method proposed and the measurement methodology.
     3. Include possible strategies if issues arise and any plans for the development of combined measures that may provide greater validity than an individual measure.
     4. Include the sourcing of all components of the analytical methods proposed.
     5. Provide a statistical analysis plan. Include a power analysis to justify the number of participants or samples per group.
     6. For validation studies, describe the strategies for maximizing reproducibility, including standard operating procedures for pre-analytical, analytical, and post-analytical stages.
     7. Please describe your regulatory and commercialization strategies.

  5. Description of Investigative Team and Resources

     1. Describe the investigative team and explain how specific expertise of each member will contribute to completing the study objectives.
     2. Where internal expertise is not available, include a description of external partners (e.g. consultants, contract research organizations (CROs) that will help to execute the experimental work.
     3. Discuss the inclusion of any consultants with assay development expertise that were involved in the design of preclinical or clinical studies or the development of the commercialization plan.
     4. If applicable, discuss relationships with commercial diagnostics platform companies or plans to partner. Summarize the materials, technologies, and/or expertise provided by these collaborators.

  6. Intellectual Property

     1. Provide information on existing IP and stage of prosecution.
     2. If no IP currently exists, describe the projected plan to generate IP; note if you expect the project to generate new IP.
     3. Indicate any freedom to operate issues.

  7. Other Support

     1. List other financial support, awarded and pending, and include grant title, principal investigator, percent effort of investigator, granting agency, amount, and projected funding period.
     2. Indicate any overlap between the aims or investigator effort from other funding with the proposed work.

  8. References

     1. References do not count towards the 6-page limit.
• Budget and Justification (no page limit)

  1. Please complete and provide the following forms in the full proposal PDF:

     1. PHS398 Form: Complete the template PDF (download here) or Word version (download here). Download instructions here.
     2. Budget and Justification: Complete the template and provide a brief justification for each line item. Download the template here. NOTE: You will also be asked to submit this as a CSV file in a separate location in the application.

  2. Proposals must outline how they will spend $250K to $1M in direct costs. Additional funding will be provided for indirect costs (up to 15%)

     1. Proposals do not need to provide budget details for NACC to ingest and share data.
     2. Please review permissible costs listed in the “Before Getting Started” section above.
• Biographical Information (no page limit)
  1. Include a NIH biosketch for each of the key personnel listed on this project.
  2. For instructions, please visit: https://grants.nih.gov/grants/forms/biosketch.htm
• Study Population Worksheet (no page limit)
  1. Complete the Study Population Worksheet. Download the template here.
  2. If using specimens from an existing cohort, a letter of support from the PI of the study is required.
• Letters of Support (no page limit)

  Letters of support from ADRC’s should be included as part of your proposal.

Contact Us#

Partner Information#

About the ADRC Program

The National Institute on Aging (NIA) funds 33 Alzheimer's Disease Research Centers (ADRCs) at major medical institutions across the United States. Researchers at these Centers are working to translate research advances into improved diagnosis and care for people with Alzheimer's disease, as well as working to find a treatment or way to prevent Alzheimer's and other types of dementia. In addition, NIA funds four Exploratory ADRCs that are designed to expand and diversify research and education opportunities to new areas of the country, new populations, and new areas of science and approaches to research.

Learn more about the ADRC Program here

About NACC

The National Alzheimer's Coordinating Center (NACC) functions as the centralized data repository, and collaboration and communication hub for the National Institute of Aging's (NIA's) Alzheimer's Disease and Research Centers (ADRC) Program, which currently includes 33 centers and 4 exploratory centers across the United States.

The National Alzheimer's Coordinating Center was established in 1999 by the National Institute on Aging/NIH to facilitate collaborative research. Using data collected from NIA-funded Alzheimer's Disease Research Centers (ADRCs) across the United States, NACC has developed and maintains a large relational database of standardized clinical and neuropathological research data. In partnership with the Alzheimer's Disease Genetics Consortium (ADGC), the National Centralized Repository for Alzheimer's Disease and Related Disorders (NCRAD), and the NIA Genetics of Alzheimer's Disease Data Storage Site (NIAGADS), NACC provides a valuable resource for both exploratory and explanatory Alzheimer's disease research. NACC data are freely available to all researchers.

Learn more about NACC and NACC Data here

About Gates Ventures

Gates Ventures is the private Executive office of Microsoft co-founder and philanthropist Bill Gates and was founded 2008 in Kirkland, Washington, United States. It comprises his personal staff, a think tank on problems of health and global development, and a technology investment portfolio.

Learn more about Gates Ventures here

FAQs#

Program and Program Partners

• Is EEG data included in the (NACC) database?

  EEG data is not currently included in NACC’s dataset. Learn more about NACC data here.

• Will this opportunity be repeated next year?

  This is a new program launched by NACC in collaboration with Gates Ventures. We have yet to determine whether the program will be continued in following years.

Eligibility and Application Requirements

• When is travel an approved cost?

  The RFA states that travel may not be an allowable cost unless special circumstances are approved. Special circumstances may include necessary travel for project activities integral to data collection or the overall project. Please reach out to naccmail@uw.edu to determine if travel costs for your proposal are approved.

• Who should I list as the prime sponsor on my grants and finance documentation?

  Please list University of Washington – as NACC will be distributing the subawards for projects who are awarded funding.

• Are non-US based companies eligible for funding?

  Yes! Non-US companies are eligible for funding as long as they have at least two Alzheimer’s Disease Research Center (ADRC) Program collaborators.

  All data generated or used in each pilot project must be made accessible to the research community through the National Alzheimer's Coordinating Center (NACC) Data Platform.

• Are postdocs eligible to be the PI on the application?

  If the PI on the application is a postdoc, most institutions will ask for a faculty sponsor when they submit and go through their internal approval process.

  If that is the case for your institution and your proposal is awarded funding, that award may need to be listed under the faculty sponsor's name.

• Is the requirement 2 different ADRCS, or can it be 2 different investigators at a single ADRC?

  At least 2 ADRC collaborators from different institutions are required

• Are applicants' budgets held to the NIH salary cap?

  As this grant is not funded by NIH, there is no requirement to adhere to the NIH salary caps.

• Are sites under the requirement to adhere to the single-site IRB?

  There is no requirement to adhere to the single-site IRB – IRB requirements are met so long as each site is clear to collect the data described in the proposal and share this data with NACC.

• Can the institutions involved in an application submit the budgets separately for the proposal?

  Each of the four institutions as well as any technology partners on your application can submit a separated budget for your application. NACC would then setup subawards for each institution to maximize the amount of funding that goes towards the actual research.

• The requirements for the RFA state that "industry partnerships are strongly encouraged" - should we interpret this statement to mean that we should not apply for the program if we are not currently partnered with a wearable device company?

  This statement is meant to encourage those applying to have a strong plan for how their pilot proposal will be implemented across several piloting sites. An industry partnership or plan that supports this would make for a stronger application.

• The application asks for IRB approval that seems to be needed at the time of the application. Can you confirm, expand on this?

  IRB approval is not required as part of the application process, but a stronger application would include details and/or a timeline about securing IRB approval.

• Regarding the 6-page limit of the research proposal, are f (other support) and g (IP) included in the 6-page limit or can these be added as appendix?

  2a-2g, including ‘other support’ and ‘IP’ are meant to be included in the 6-page research proposal.

Partnerships between Academia and Industry

• Are there any specific requirements to put a foreign (non-US) subaward in place?

  Yes, there are several requirements that NACC/University of Washington must follow to set up subawards with foreign entities. Please reach out to naccmail@uw.edu for more information.

• What mechanism does NACC have for tech companies to pitch new technologies/proposals to ADRCs?

  For the purposes of facilitating partnerships with the purpose of submitting a pilot proposal only – NACC will connect tech companies with ADRC’s who have indicated their interest in being approached by tech companies looking for partners for the NACC & Gates Ventures Digital Data Pilot Program. Email us at naccmail@uw.edu

• Should ADRC researchers also email NACC to get connected with tech companies?

  NACC does not currently have a list of possible tech companies to partner with, but feel free to reach out to naccmail@uw.edu and we will connect with the Clinical Task Force Technology Workgroup to determine if any connections can be made.

• Can we partner with international investigators? Can you speak about the issue of tech companies that share IP secrets with certain foreign countries being barred from US SBIR funding?

  All applicants are welcome, including international collaborators. As long as the proposal includes at least 2 collaborators from a member of an ADRC.

• What would an ADRC partnership look like for a company with a focused proposal already?

  This is highly dependent on the ADRC(s) involved. Some may be open to simply joining as a pilot site while others will want to be more involved in the proposal writing process.

Data and Data Sharing

• Will EEG data be considered a digital biomarker?

  Yes, it could be.

• Could you define Raw Digital files? Is that the raw sensor data or may that be up to the company's discretion?

  Yes, raw digital files include raw sensor data; a company will need to decide what is possible while protecting IP. For example, sharing raw sensor data but not any derived measures that rely on proprietary algorithms would fulfill the criteria of sharing raw digital data files without exposing company secrets.

• Are there any system requirements for sharing data in NACC’s cloud?
  • All data generated or used in each pilot project must be made accessible to the research community through the National Alzheimer's Coordinating Center (NACC) Data Platform.
  • NACCID must be affiliated with data
  • Documentation on datatype, metadata descriptors, etc. Should be provided
  • Tooling & code necessary for QC/processing of data should be provided
• In terms of confidential data sharing, privacy and operation: is the plan to stand up a shared data commons for these initiatives that is based on enforced standards and leveraging cutting-edge technologies such as homomorphic encryption and zero-knowledge proofs, etc.? Or is every initiative going to be using bespoke data collection doing their best to adhere to data sharing standards? As a negative counter-example - during the Covid-19 defense, the various initiatives doing voice-based diagnostics were collecting slightly different data sets for no scientific reason, resulting in the failure of all of their respective machine learning approaches due to limited data - whereas if there were clearly defined and enforced standards their data could have been shared and strengthened each of their proprietary approaches (without harming their IP, etc.)

  NACC is currently working with the Global Research Integration Platform team to develop tools to enable better privacy protection, harmonization, and data management and processing. These open source tools will be made available on the NACC website with the assumption that these are first generation tools that the scientific community will iterate on since there are no currently accepted gold standards. Since different data types in general, and digital data in particular will also have nuanced differences, it is likely that there will be a hybrid between recommended approaches that can be used uniformly versus those that will need local customization.