CEDAR Seed PilotAward

Request for Applications

About the cedar seed award

The Cancer Early Detection Advanced Research (CEDAR) center Seed Pilot Award funds pilot projects to cultivate outstanding translational early cancer detection research, assist in the generation of preliminary data, and lead to follow-on funding. TheSeed Pilot Awardprogram is intended to support technological, basic biology, or population-based research that is focused on early cancer detection. Scientific excellence, research team, justification of the funds, milestones, and alignment with this mission will be the key review elements for applications. Interdisciplinary research, in which investigators from disparate scientific areas and across ranks collaborate to foster unique approaches, is strongly encouraged across all CEDAR endeavors.

IMPORTANT DATES

Upcoming application deadline:Friday1stDecember 2017(our goal is to invite applications up to twice yearly)

After proposals have been reviewed by the CEDAR Seed Award committee, selected finalists will be invited to give a short presentation to an external panel during February (date T.B.A.).

Summary of AWARD oppurtunities

  • Funds are available to support up to five awards for each award cycle
  • Each award provides up to $120,000 of direct costs (plus 22% OCA) over up to 18 months, and regular contact with a CEDAR Project Facilitator in order to accelerate development
  • Funding will be distributed in 3 tranches, with each tranche dependent upon successfully meeting milestones
  • Priority is given to proposals that include key team members from multiple disciplines
  • Two of the awards will give priority to applications proposed by non-faculty leads (graduate student, postdoc, etc.)

‘Before you submit’ checklist

Please ensure that you complete everything in this list before you submit your application:

Does your project meet the remit and eligibility criteria?→ Section A

Have you completed your Abstractsand two-page Project Proposal?→ Section B

Have you completed aBudget Form?→ Section C

Have you completed aMilestones Form? → Section D

Have you read the Review and Post-Selection Processes?→ Section E

Do you have a Mentor Letterand Letters of Support?→ Section F

Have you completed the IP Form (if applicable)?→ Section G

If you have completed all of the above, then please submit your application here.Documents may be uploaded in Word or PDF format, as separate files or as one combined document. Please contactBartu Ahiska with questions.

Remit of the CEDAR SEED PILOT Award

What is suitable for the award?

Our goal for early detection is to detect lethal disease at an early stage where treatments would not significantly affect the quality of life for patients. To meet this goal, early detection research includes the study of pre-malignant diseases or early stage cancers (stage 1 or at most 2). We want to understand the basic biology of tumor development as it moves from normal to pre-malignant to malignant transformation, identify lethal from non-lethal disease prior to treatment, and study therapeutics that prevent cancer formation. We will consider projects addressing challengeswithin the followingfocus areas:

  • Basic Science– Including but not limited to understanding pre-malignant to malignant transformation,such assystemic and local immune microenvironment, cell-cell interactions, and metabolism in early stage disease. Studies of genetic mutations should focuson pre-/early malignant stages before significant tumor growth or heterogeneity.
  • Early Detection Technology– Including but not limited to new techniques or devices for fluid biopsies, and newin vivo or ex vivo imaging modalities or improvements.
  • Risk Assessment and Population Health– Including but not limited topopulation genomic risk assessment, environmental exposure correlation with risk, etc. Theaward is not intended for cohort development, but proposals to investigate methods for cohort development or develop teams to build cohorts are acceptable. Human cohorts could consist of normal (no evidence of disease), high risk, stage 0 (pre-malignant), stage 1 or (at most) stage 2 disease. If you are interested in cohort development, please consider applying to the CEDAR Seed Clinical Cohort Award.
  • Prognosis of lethal vs. non-lethal cancer– Including but not limited to determining biomarkers that indicate a tumor will become aggressive cancer, imaging or pathology assays that add prognosis assessment to a diagnosis, etc.Early detection biomarker discovery or validation efforts should be focused on fluid biopsies (e.g. nucleic acid, protein, extracellular vesicles), physiological measurements, or pre-malignant disease biopsies.
  • Early Preventive Therapy– Current funding for therapy is only open to studying treatments that prevent pre-malignant to malignant transformation or normal to pre-malignant states.

What is not suitable for the award?

The award does not include studying late-stage disease or response to therapy. We will not consider proposals to test or develop therapeutics for late stage disease. If you are primarily interested in help with commercialization, please consider applying for the Biomedical Innovation Program (BIP) pilot awards instead. More information can be found here: http://www.ohsu.edu/xd/research/centers-institutes/octri/funding/bip-program.cfm

If you are interested in cohort development, please consider applying to the CEDAR Seed Clinical Cohort Award.

Eligibility

Teams can be led by any OHSU employee regardless of rank, including but not limited to graduate students, postdoc fellows, staff scientists and faculty.CEDAR Seed Pilot Awards are intended to support new, innovative projects. Projects may be an extension of other work, but cannot overlap with any funded project or be used as bridging support for projects for which funding has lapsed. We encourage applications from young investigators with no other sources to fund these pilot projects and who may need help from CEDAR to form a complete team, and from senior investigators with the purpose of fostering collaborative exploration of new areas and ideas with high potential for impact in the clinic, including the incorporation of emerging technology. Funds are not transferrable to another institution, and trainee applicants should plan to complete their funded projects before leaving OHSU.

AbstractS(please provide non-confidential abstracts that may be shared with CEDAR)

Please include a technical abstract of no more than five sentences.

Please include an abstract suitable for a lay audience of no more than four sentences.

Project Proposal

Please use the following template, and limit proposals to two pages (not counting references).Pleaseinclude:

  • Proposed solution

–Significance of the project in addressing an important problem in one of the five CEDAR focus areas

–Impact of the project in advancing scientific knowledge and the clinical relevancy

–What will you learn if your project does not work as planned?

  • Team

–Who will be working on the project? Include team member descriptions (e.g. expertise, role, inclusion justification)

–(If appropriate) Teams should list team members from bio-computation

–If you are missing expertise and would like help adding to your team, please identify these so we can help

–Identify any external parties involved and what they bring to the project

  • Preliminary data (if warranted) – figures do not count against page limit

–Publications, presentations or patents that support feasibility and future clinical demand for project results

  • Alternatives

–What are the shortcomings of alternative clinical solutions, methodologies or technologies?

–What makes your proposal different to these alternatives?

  • Timeline and milestones

–Specific aims and the proposed timeline for completion of the project within up to 18-months

–Plans to drive the project beyond the pilot (e.g. follow-on research funding, or commercialization strategy)

–(If relevant) What are the regulatory paths for your technology and hurdles you may face?

–Additionally, please use the Milestones Form (Section D) to list regular, realistic, measurable milestones for every 6 month period (milestones may evolve along the way).As projects will be evaluated based on meeting these, they should be actionable checkpoints where a go/no-go decision can be made

  • Budget and justification

–Please use the Budget Form (Section C) to give a description of your use-of-funds and other active funding sources

Formatting requirements:Please use the template below using font size ≥10 points and one of the following recommended fonts: Arial, Calibri, Georgia, Helvetica, Palatino Linotype.

Budget and justification

Each award provides up to $120,000 of direct costs (plus 22% OCA) overthree budget periods up to 18 months. Allowable costs include: Personnel (a maximum of 5% of the award may be used for total faculty support, e.g.$6,000 for a $120,000 project); Supplies; Animals (please be as specific as possible); and Other Expenses (e.g. biostatistics/informatics support, software, travel).Equipment that is essential for the study, and is not otherwise available, may be requested (purchased equipment will be considered CEDAR equipment available to all projects, and be located in CEDAR space).Awardees may apply to the CEDARTravel Fund to present Seed project results at a conference.

($) / 6 months / 12 months / 18 months
Personnel
(total faculty salary support limited to 5% of award)
Supplies
(list in categories)
Animals
(as specific as possible)
Other
(e.g. biostatistics/informatics support, software, travel)
Total

Please give a justification of your budget bymajor categories, and details of any other active funding sources for the project.

PROJECT MILESTONES

Funding will be distributed in 3 tranches, with each tranche dependent upon successfully meeting milestones. Milestones should be regular, realistic, measurable checkpoints that take place every 6 months. As projects will be evaluated based on meeting these, they should be actionable points in time where a go/no-go decision can be made. The number of milestone you set for each milestone review period can vary.

6 month milestones:

Aim 1:

- Milestone 1:

- Milestone 2:

Aim 2:

- etc.

12 month milestones:

18 month milestones:

Review process

Project Proposals will be reviewed by the CEDAR Seed Award review committee. Only applications that meet our eligibility criteria will be considered. Applications that are selected for more extensive review will be invited to showcase their plans with a short presentation to a review panel which includes external reviewers.Each proposal will be evaluated for:

  • The problem (25%) – A priority for this award mechanism is to promote outstanding research addressing an important problem in one of the five CEDAR focus areas listed above.

–Does the project address an important problem in at least one CEDAR focus area?

–If the aims are achieved, will scientific knowledge or clinical practice be significantly advanced?

  • The team (25%) – Projects must demonstrate that the team has appropriate expertise to complete the aims to a high standard, and crucially, that there is a multidisciplinary collaboration among scientists of diverse backgrounds or ranks.

–Does the team have the appropriate expertise to complete the project with high scientific quality?

–Does the project promote multidisciplinary collaboration among a diverse set of scientists?

–Does the team identify any shortcomings and demonstrate willingness to seek collaboration where needed?

  • Innovation (20%) – Theaward mechanism is designed to foster creative solutions that address a critical market need, or generate novel results that are likely to open new avenues of cancer investigation.

–Will the project provide results that are novel and likely to open new avenues of cancer investigation?

–Does the project develop novel technologies or approaches for which there is a strong market need?

–Are any new technologies patentable, or are there any foreseeable third party IP problems?

  • Feasibility and impact (20%) – Priority will be given to well-developed projects where this grant can make the greatest difference. We will assess proposals on their risk level and efficient use-of-funds.

–Is it likely that the proposed useoffunds will move the technology or knowledge to the next level?

–Are potential barriers recognized, and what are the plans to overcome them?

–Does the project require the grant money? Are there alternative sources of funding that are readily available?

–Are the funds used wisely, and will the resources be sufficient to complete the project on-time and on-budget?

  • Post-grant strategy (10%) – A purpose of this award is to support early-phase research that will continue and grow beyond the funding period. Priority will be given to projects with a well-formulated follow-on funding strategy.

–Is there a realistic, ambitious plan to continue to drive the project beyond the pilot?

–Is the project capable of attracting follow-on national funding, or show a commercialization path?

Post-selection process

  • Logistics – If your project is selected, an award letter will be issued with further information regarding account setup. This timeline requires internal approvals and may take some time if IRB/IACUC/IBC compliance is applicable.
  • Team meetings – Weadvise that you hold regular meetings with all key members of your interdisciplinary group. We ask that you invite a self-appointed Mentor (see Section D) and a CEDAR-appointed Project Facilitator once monthly to these working sessions. The Project Facilitator’s primary role is to help remove roadblocks, such as by assisting with access to CEDAR resources or expertise, andhelp you focus on meeting your milestones.
  • Milestone reviews – Your team will be invited to give a short presentation every 6 months during your Milestone Review. Projects will be evaluated based on meeting milestones. The Milestone Review is used to make a go/no-go decision based on meeting your milestones, and gives you an opportunity to make adjustments to your timeline and future milestones.

MENTOR LETTER

We strongly recommend that you self-appoint a Mentor to support your team.

  • Somebody who is outside of your project (“close, but not too close”) and brings a new perspective;
  • An expert who asks the hard questions to the scientific team during the monthly meetings;
  • Should commit to join your team meetings once monthly (i.e. time commitment is 1hr/ month).

Please include a Letter of Support from your project Mentor as part of your CEDAR Seed Pilot Award application.

DEPARTMENT CHAIR LETTER

  • Applications should include a letter from the Department Chair acknowledging the proposed project and the+22% OCA associated with this award.

Additional letters of support

  • Each major team member should include a Letter of Support indicating their involvement in the project as stated in the proposal;
  • Optionally, additional letters of support may also be included but are not required.

Intellectual Property(IP) form

This form enables the CEDAR SeedAward committee to evaluate whether aTTBD disclosure is required, and to identify any issues arising from shared IP ownership and existing patent licenses. This form may be omitted if you have nothing to declare.

Existing OHSU and third-party IP

Please describe any of your existing invention disclosures that will be used in the proposed project, and/or any third-party IP and associated issues that may be faced (e.g. use of materials covered by a material-transfer agreement (MTA), use of a patented technology component).

Existing invention / Patent filings and status
(if any) / Details of any patent licenses,
or shared IP ownership with non-OHSU entities
e.g. Composition for a recombinant polypeptide blocking pathway X / e.g. TTDB disclosure #XXXX, Granted US Patent / e.g. Joint invention with 3rd-party Co., exclusive world-wide license granted within Field Y

Novel technology

Please give details of any potential new inventions, material, or copyrightable work (“Technology”) within the proposed scope of work.

Novel Technology,
or afeature of novel Technology / Benefits / Details of any public disclosures,
non-OHSU contributors or external funding sources
e.g. Composition for a recombinant polypeptide blocking pathway X / e.g. Use as a therapeutic for case Y with adjuvant Z / e.g. Historic and anticipated publications and presentations describing the Technology

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CEDAR SeedPilot Award