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2022-2023 Request for Applications

ITHS Early-Stage Product Development Award

ITHS Early-Stage Product Development Award

2022-2023 RFA

ITHS is offering an Early-Stage Product Development (ESPD) Award 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
    11:59pm August 1, 2021
  • Notice of Invitation to Apply
    August 20, 2021
  • Application Deadline
    11:59pm September 27, 2021
  • Awardees Notified
    December 20, 2021
  • Period of Performance
    March 1, 2022 – February 28, 2023

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? 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. 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.
  2. The application process will begin with a letter of intent succinctly addressing the 5 key questions that reviewers will use to evaluate the proposal.
  3. Selected teams will be invited to submit full applications based on information in the letter of intent.  ITHS consultative resources will be available to assist teams in preparing full applications.
  4. 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.
  5. 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.
  6. 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.
  7. Success will be defined by completion of milestones and data to support a go/no-go decision for further product development. In the post-award phase, ITHS could provide research coordination, data management support, or statistical expertise to achieve further project goals as needed.
  8. Plan to spend your money in 1 year. No-cost extensions will not be allowed. 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.
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 in order 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
A. 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.

B. 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 Page
2) Abstract (250 word maximum)
3) Research Plan, 6-pages (references do not count toward page limit)
57 KB4) Project Timeline – 1-page
5) Budget and Budget Justification29 KB5a) Budget 37 KB5b) Budget Justification
6) 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.

A general note about conflict of interest: A reviewer would have a conflict of interest if they are the applicant’s mentor, dept. 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.

28 KB7) NIH format Biosketches for all investigators (senior/key personnel)
C. Timeline

  • Letter of Intent Deadline – 11:59pm August 1 2021
  • Notice of Invitation to Apply – August 20, 2021
  • Application Deadline – 11:59pm September 27, 2021
  • Awardees Notified – December 20, 2021
  • Period of Performance – March 1, 2022 – February 28, 2023

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

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 Carly Rowe (see below). ITHS can provide referrals to possible collaborators and consultants who could assist with the development of your project.

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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

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University of Washington specific question: Does this award have to go through the Office of Sponsored Programs (OSP)? Is an eGC1 required?

No, this is an internal grant and does not need to be routed through OSP and does not require an eGC1.

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Are supplemental documents allowed?

No, supplemental documents are not allowed.

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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.

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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.

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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.

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What is a Contact PI?

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.

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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.

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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.

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Can a community or industry partner be my collaborator?

Yes, we as long as the main, or Contact PI must be a faculty member at an academic institution.

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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.

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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.

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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.

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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.

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Page last modified: Sep 9, 2021 @ 10:23 am (PST)