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2025-2026 Request for Applications

ITHS Early-Stage Product Development Award

ITHS Early-Stage Product Development Award

2025-2026 RFA

ITHS offers ESPD Awards to help translate clinically relevant research discoveries toward development of commercial products that improve human health. Projects should be designed to demonstrate or strengthen critical evidence that the envisioned product accomplishes its health-related purpose with respect to safety, efficacy, scalability, feasibility or clinical utility (i.e., proof of concept).  As examples, funds for devices could be used to create or refine prototypes, evaluate usability, assist with regulatory filings, or conduct an early-stage clinical study. Funds for therapeutic products could be used to identify or develop suitable animal models, produce small batches of the product, evaluate toxicology, pharmacokinetics or pharmacodynamics or prepare for IND submission. Funds for mobile health products could be used to evaluate effects of human factors, assess interface design, develop software coding, assist with regulatory filings, or conduct an early-stage clinical trial. Funds for diagnostic products could be used for assay development, reagent formulation, device or reader prototype design, interface design, or software coding.

Application period closed

Key Dates

The following key dates apply to this funding opportunity:

  • Letter of Intent Deadline
    July 9, 2024, 11:59pm PDT
  • Notice of Invitation to Apply
    By July 31, 2024
  • Application Deadline
    August 30, 2024, 11:59pm PDT,
  • Awardees Notified
    Early December 2024
  • Period of Performance
    March 1, 2025 – February 28, 2026

This pilot award will provide up to $100,000 toward specific project-related milestones in total costs for 1 year. No-cost extensions are not permitted.

Applications will be reviewed by a panel of scientists and engineers with commercial or investment experience.  Reviewers will focus on 5 primary questions. 1) To what extent does the proposed product address an unmet human health need? 2) How strong is the available evidence supporting proof of concept that the proposed product is safe, effective, scalable, feasible or of value? 3) To what extent does the project address a critical step or milestone necessary to advance a research discovery toward commercial development? 4) To what extent has the team planned and prepared for commercialization of the technology through evaluation of market considerations?? 5) Beyond this ESPD Award, what additional staffing, equipment, and funds will the project team need to reach the proposed project milestones?

Guidelines

Guidelines

1. Applicant Teams. The ESPD Award is built on the hypothesis that, with appropriate guidance and resources, academic research settings can serve as initial incubators for development of commercial health innovations. The ESPD Award is ideally suited for teams that have gone through iCore, Commercialization Bootcamp, or other similar training programs.  ITHS faculty or staff may be listed as active research contributors on a case-by-case basis. Please consult with ITHS (contact below) prior to application submission if your proposal includes ITHS faculty or staff.

2. Support.  This award provides up to $100,000 for 1 year of funding. The period of performance coincides with the ITHS fiscal year from March 1 to February 28/29.  All grant funds must be expended before the grant expires at the end of the fiscal year. No-cost extensions to allow use of funds that have not been expended by the end of the fiscal year will not be allowed.

  • Funding for awarded applications will be negotiated based on amounts needed to support specific accepted milestones, after accounting for all other public or private funding dedicated to the project.
  • In-kind resources will be available for awarded applications to assist with scientific, intellectual property, legal, regulatory, health informatics, digital health and health metrics support that will be available to enhance the success of the project.
  • In the post-award phase, ITHS could provide research coordination, data management support, or statistical expertise to achieve further project goals as needed.

3. Review Considerations. The review process for full applications will involve a mandatory live-session product pitch to reviewers.  ITHS will provide guidance and training for preparing these presentations. Applications should describe a trajectory of past progress, current specific aims and milestones that are feasible within the funding limits, a vision for how attainment of the proposed milestones will enable future work, and the potential scope and impact of future work if the current project is successful.

Successful applications will help reviewers determine whether the project should and could be done.

  • Describe how the project addresses an unmet health need.
  • Provide evidence supporting proof of concept.
  • Define critical milestones to support go/no-go decisions.
  • Demonstrate an opportunity for commercialization and marketing.

We have high interest in new and innovative generalizable solutions for common and persistent challenges in the conduct and outcomes of translational research through development of new methods, approaches, platforms, or tools that

  • Increase efficiency
  • Accelerate progress
  • Improve rigor and reproducibility
  • Increase the depth of impact
  • Extend the reach of impact.

See https://ncats.nih.gov/about/about-translational-science/principles for details.

Eligible Investigators
Eligible Investigators

Members at ITHS Partner Institutions, including the University of Washington, Fred Hutch Cancer Research Center, Seattle Children’s Research Institute, and other academic institutions affiliated with the ITHS in the WWAMI (Washington, Wyoming, Alaska, Montana, Idaho) region are eligible to apply for this pilot award. Collaborations may extend outside the WWAMI region; however, funds may not be transferred outside the United States. ITHS-funded faculty (those who receive salary or stipends from ITHS) and staff are ineligible to apply. Any individual eligible for external research funding according to the rules of their institution and unit may apply. Applicants who are not faculty members are required to submit a letter of support.

All Investigators on the research team must be ITHS Members to apply. Membership is free. To become a member, please complete the ITHS Membership Form.

Team Formation
  • Teams whose primary applicant is an academic faculty member, part or full time, are eligible to apply. Part time and acting faculty member applicants require a letter of support from their department head in support of the applicant’s ability to serve as PI.
  • Teams whose primary applicant is a graduate or undergraduate student are not eligible.
  • Teams whose primary applicant is an ITHS-funded faculty member are not eligible to apply.
  • Academic faculty applicants associated with a company may apply if the company has not yet licensed their intellectual property from the academic institution.
  • Applicants associated with a company that has already taken a license for its intellectual property from the academic institution are eligible to apply, but only if it is determined that the applicant sincerely intends to be an academic faculty member for the duration of the proposed work and the entirety of the work will be conducted through the academic institution.
  • Awards cannot be made to individuals who are not faculty at an academic institution.
Geography

Applicant’s primary workspace must be based in Washington, Wyoming, Alaska, Montana, or Idaho.

Other Funding Sources

Applicant may be operating under other grant funding as long as the funding does not redundantly support activities or deliverables proposed in their ESPD application.

Duration

Proposed activities must be feasibly completed within the 12-month period of performance. (eg., March 20XX to February 20XX+1). Extensions are not allowed.

Use of Funds

Funds may be used to pay for materials, contract services, and salaries for work and workers related to accomplishment of project deliverables. This requirement will generally exclude compensation for lab PI’s or company administrative staff effort, but indirect costs may also be covered when appropriate.

Application Process
Application Process

Letter of Intent

The letter of intent form must be submitted through the ITHS website before submission of the application. The form includes information on the applicant and any Co-Investigators, project title, and abstract addressing the 5 questions (up to 200 words each). Investigators who are invited to submit a full application will receive notice within  3 weeks of the letter of intent deadline.

Application

The application must be submitted through the ITHS website.

Applications will follow National Institutes of Health (NIH) formatting guidelines (see FAQ) and include:

[prettyfilelink size=”138 KB” src=”https://www.iths.org/wp-content/uploads/Cover-Page-Pilot-Awards.2021b.pdf” type=”pdf”]1) Cover Page[/prettyfilelink]

2) Abstract (250 word maximum)
3) Research Plan, 6-pages (references do not count toward page limit)

[prettyfilelink size=”57 KB” src=”https://www.iths.org/wp-content/uploads/Pilot-Proposal-Timeline-Template.2018.docx” type=”doc”]4) Project Timeline – 1-page[/prettyfilelink]

5) Partnership Plan, 1-page description of the collaboration including an explanation of the respective roles of the partners and the synergy brought about by the partnership
6) Potential use of ITHS in-kind resource, complete the ITHS in-kind resources form, select “send me a copy of my responses” and submit with your application packet
7) Generalizable Solutions, up to 1-page description if applicable (see Guidelines)
8) Human Subjects, if applicable
9) Budget and Budget Justification[prettyfilelink size=”29 KB” src=”https://www.iths.org/wp-content/uploads/Pilot-Budget-Template.2018.xlsx” type=”xls inline”]9a) Budget[/prettyfilelink] [prettyfilelink size=”37 KB” src=”https://www.iths.org/wp-content/uploads/Pilot-Budget-Justification-Sample.2018.docx” type=”doc inline”]9b) Budget Justification[/prettyfilelink]

10) Letters of Support – Letters of Support are not required unless you are an instructor or acting faculty member. If you are an instructor or acting faculty member, you will need to include a letter supporting your eligibility to serve as PI from your Department head (or equivalent).

[prettyfilelink size=”28 KB” src=”https://www.iths.org/wp-content/uploads/biosketch-blank-format-rev-12-2020-exp-02-28-2023.docx” type=”doc”]11) NIH format Biosketches for all investigators (senior/key personnel)[/prettyfilelink]
Not included in the above document:
Suggested Reviewers – You will also be asked to provide five suggested reviewers, including the following information for each: 1) Name, 2) Title, 3) Institution/Organization, and  4) Email Address. Reviewers are not required to be within the University of Washington.

A general note about conflict of interest: Reviewers would have a conflict of interest if they are the applicant’s mentor, department chair, spouse, or close relative; or if they currently work together on manuscripts, grants, or business ventures. Simply being in the same department or division is not, in and of itself, a conflict of interest.

Timeline

  • Letter of Intent Deadline – 11:59pm July 9, 2024
  • Notice of Invitation to Apply –  By July 31, 2024
  • Application Deadline – 11:59pm  August 30, 2024
  • Awardees Notified – Early December 2024
  • Period of Performance – March 1, 2025 – February 28, 2026

ITHS is funded through a CTSA grant from NIH’s National Center for Advancing Translational Sciences (NCATS). NCATS requires the review and approval of all pilot grants involving human subjects research before funds are released. Therefore, if your proposal is awarded funding and involves human subjects research, additional documentation will be required. NCATS review and IRB review can be concurrent, but final NCATS approval is contingent upon IRB approval.

Frequently Asked Questions
FAQs

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