Permanent link: https://www.iths.org/?p=27367
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
Faculty 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. An acting faculty member or instructor is eligible to apply only if the Department head provides a letter supporting the applicant’s eligibility to serve as PI.
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:
138 KB1) Cover Page2) Abstract (250 word maximum)
3) Research Plan, 6-pages (references do not count toward page limit)
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 resources and training opportunities
7) Generalizable Solutions, up to 1-page description if applicable (see Guidelines)
8) Human Subjects, if applicable
9) Budget and Budget Justification29 KB9a) Budget 37 KB9b) Budget Justification
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).
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.
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
Research Innovation Awards
How could I find out whether my project is a good fit for this award?
All investigators considering whether to submit an application for this award are encouraged to contact Lindsie Boerger (see below). ITHS can provide referrals to possible collaborators and consultants who could assist with the development of your project.
Are there any restrictions on indirect costs applied to these awards?
Applicant institutions must use a rate no higher than the approved, federally recognized indirect cost rate negotiated between the applicant institution and the federal government. ITHS would like to maximize funds to directly support the investigator’s research and encourages investigators to work with their Office of Sponsored Programs to obtain a waiver to reduce indirect costs on the project.
The Fred Hutchinson Cancer Research Center and Seattle Children’s have agreed to consider requests for indirect cost waivers for ITHS pilot awards from their faculty.
- ITHS members whose research program is based at Fred Hutch, who wish to apply for ITHS pilot awards are required to go through the standard institutional procedure for requesting a waiver of facilities and administrative (F&A) costs, as described here: http://centernet.fhcrc.org/CN/depts/osr/policies/forgonefaa/
- ITHS members whose research program is based at Seattle Children’s, who wish to apply for ITHS pilot awards are required to go through the standard institutional procedure for requesting a waiver of facilities and administrative (F&A) costs, as described here: http://www.seattlechildrens.org/pdf/RIA-410.pdf
No, this is an internal grant and does not need to be routed through OSP and does not require an eGC1.
Are supplemental documents allowed?
No, supplemental documents are not allowed.
Are there any formatting requirements?
Applications will follow National Institutes of Health (NIH) formatting guidelines (https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm), including the following:
Font (size, color, type density) and Line Spacing
- Font size: must be 11 points or larger (smaller text in figures, graphs, diagrams and charts is acceptable as long as it is legible when the page is viewed at 100%).
- Type density: must be no more than 15 characters per linear inch (including characters and spaces)
- Line spacing: must be no more than six lines per vertical inch.
- Text color: must be black (color text in figures, graphs, diagrams, charts, tables, footnotes and headings is acceptable).
- We recommended the following fonts, although other fonts (both serif and non-serif) are acceptable if they meet the above requirements:
- Arial
- Garamond
- Georgia
- Helvetica
- Palatino Linotype
- Times New Roman
- Verdana
Citations
- We do not require a specific citation format.
Paper Size and Margins
- Use paper size no larger than standard letter paper size (8 ½” x 11”).
- Provide at least one-half inch margins (top, bottom, left, and right) for all pages. No applicant-supplied information can appear in the margins.
Do figures and references count toward the 6-page Research Plan limit?
Figures DO count toward the 6-page limit, but references can be in addition to the 6-page Research Plan.
No, only faculty level investigators are eligible to apply.
Can non-faculty apply as a Co-PI or Co-I?
Yes, however the main or Contact PI must be a faculty member at an academic institution.
ITHS requires the applicant to designate one of the PD/PI(s) as the Contact PD/PI. This person is responsible for communication between the PD/PIs and ITHS, but has no special authorities or responsibilities within the project team. In many ways, a contact PD/PI is analogous to a corresponding author on a publication. The Contact PD/PI must serve as a member of the PD/PI team and must meet all eligibility requirements for PD/PI status. In those projects where there is an identified project coordinator, the coordinator could serve as Contact PD/PI or that role could be assigned to another PD/PI. It will be possible, and may even be desirable, for the grantee institution to periodically designate a change in Contact PD/PI. For example, it may be desirable to rotate the role of Contact PD/PI among the multiple PD/PIs on an annual basis at the time of grant renewal. Note that the Contact PD/PI must be associated with the applicant/awarde institution.
Do you expect the PI or Co-PI to have a specific amount of effort committed in the form of salary?
ITHS will follow NIH Policy: Each PD/PI must have measurable effort (greater than zero), and the level of effort must be adequate to achieve the proposed goals. The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. “Zero percent” effort or “as needed” are not acceptable levels of involvement for those designated as Senior/Key Personnel.
Can there be more than 2 Co-PIs or Multiple PIs?
Yes, you may have more than 2 PIs, however 1 person will be identified as the Contact PI for administrative purposes.
Can a community or industry partner be my collaborator?
Yes, but the main, or Contact PI must be a faculty member at an academic institution.
Could an investigator apply for this program with a pending faculty appointment?
Pilot recipients must be a faculty member at an academic institution by July 1, before the period of performance. For example, if the period of performance is March 2022-February 2023, the appointment must be by July 1, 2021.
I have previously been awarded funds by the ITHS. Am I still eligible to receive this award?
Yes, previous ITHS awardees are eligible to receive additional funding.
Does the NIH cap apply to this application?
Yes, these funds come from the NIH through the National Center for Advancing Translational Sciences (NCATS) and so the NIH cap does apply.
Can funds be dispersed prior to IRB approval to aid the application process?
No, funds cannot be dispersed until IRB approval is confirmed. Applicants will have the opportunity to provide Just-in-Time approvals prior to the start date.
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.
Contact Us
For information regarding this pilot program, contact:
Lindsie Boerger
Project Manager
Institute of Translational Health Sciences
850 Republican Street, Box 358051, Seattle, WA 98109
lboerger@uw.edu / www.iths.org
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