Disease Team Grant Application 2018-2019Name of Principal Investigator:

OIRM DISEASE TEAM GRANT APPLICATION

All Investigators who intend on submitting a grant application must first complete and submit a Notice of Intent by Friday, June 30th 2017 by 4:00PM EST to orimgrants@oirm.ca. Those who do not meet the eligibility requirements will be informed by Friday July 14th 2017. Otherwise, all other applicants should proceed to the full application stage.

Please review the Disease Team Guidelines prior to completing the application. The full grant is due Friday, October 27th 2017 by 4:00 pm EST to oirmgrants@oirm.ca. Late or incomplete submissions will not be accepted.

Applications should use single spaced, Calibri (minimum size 12) font, with 1-inch margins, and name the file using the Lead PI name (i.e. Joe Smith – DT.docx). The maximum size of the submission should not exceed 10MB. Please adhere to word and page counts where stated, any content that exceeds these counts will be deleted from the final document provided to reviewers.

Application Package (checklist):

Document 1 – Application Form: A single Word document (do not format into a PDF) that includes the completed application form (Sections 1 to 8 below) in single-spaced, Calibri (minimum size 12) font, with 1-inch margins. Please enter the Principal Investigator’s name in the headings of the document and in the title of the file (i.e. Joe Smith - DT.docx). You may delete the specific section instructions but do not delete section headings.

Document 2 – CVs: A single PDF file with CVs of all Investigators requesting funding from OIRM. Please use the CIHR Canadian Common CV format. For the publications section, only list up to 25 selected publications (relevant to the proposal), the presentation section of the CCV is not required. CVs for Collaborators (i.e. those not requesting funds) and Highly Qualified Personnel do not need to be submitted. Please also complete these tables in section 2.

Document 3 – Partnership Letters: A single PDF file that includes eligible partnership letters of support for the 12-month funding period from March 15/18 to March 14/19. See section 4 for more details.

Document 4 – Budget: Use the Excel budget template file provided. This grant competition is based on a 12-month funding period and is up to $750,000 in value. In addition to your initial 12-month budget, please also provide a high level projected budget for the following 1 year (Mar 15/19 to Mar 14/20). There is no guarantee of receiving funding for subsequent years. It is expected that some teams that have not met targets will be discontinued and new teams will be funded in future years. Budget expenditures should follow CIHR guidelines, in accordance with Tri-Agency Financial Guidelines. Projects that do not meet these requirements may be considered ineligible for this competition. In addition, budget justifications are to be included in section 7 of the application form.

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

Document 5 – Signatures: A single PDF file of the signatures page, completed and signed by both parties.

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

1. PROJECT OVERVIEW

Scientific Project Title (15 words max):

Plain Language Project Title (15 words max) – For successful proposals, this title will be used in press releases/website content:

Principal Investigator – OIRM Investigator who will be responsible for managing the project, including allocation of budgets and progress reporting to OIRM (Co-Principal Investigators are not accepted):

Disease Impact – In one sentence, identify what major impacts your proposed research will have on the relevant disease or condition over the next two years (Mar 15/18 to Mar 15/20):

Project Short-term Deliverables – Identify three key project deliverables to be achieved within the 1st year of grant funding from Mar 15/18 to March 14/19 (12 month grant funding period):

Deliverable 1: Deliverable 2: Deliverable 3:

Long-term Translational Plan (1 page max) – Provide a clear description of your long-term clinical translational plan for the proposed research over the next two years (Mar 15/18 to Mar 14/20) including how the proposed grant will further this long-term plan:

Clinical Readiness – What is the level of clinical readiness for your proposed project during the proposed funding period (Mar 14/18 to Mar 15/19), please select all that apply:

Pre-clinical small animal Pre-clinical large animal Cell manufacturing for clinical grade and quantity Clinical Trial Application to Health Canada Research Ethics Board application Initiation of a clinical trial Other, please detail:

Executive Summary (500 words max) – Provide a summary in lay terms of the proposal highlighting project objectives and deliverables, describing how the research is readily translatable to human health, and relating how the goals of the proposal will benefit Ontarians in the long term. Identify key team members and partners. Describe the potential of commercialization impact in terms of out-licensing or company creation. For successful proposals, this summary may be used in press releases/website content.

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

2. Project Team

In the tables below, list all OIRM Investigators (including the lead PI) and Collaborators. OIRM Investigators are those requesting OIRM funding, while Collaborators are Investigators who are not requesting OIRM funding but who will be collaborating on the project. Please note, investigators requesting OIRM funds must be OIRM Investigators with full-time faculty appointments in Ontario prior to the submission of this application and must maintain this position for the entire length of the funding period.

Provide names, position, institutional affiliations and contact information. As well, include a 2 to 3 line description of the role of each member with respect to the proposed research, clearly identifying their expertise and strengths and how their inclusion will benefit the proposed research.

OIRM encourages collaborations with Canadian and international scientists who would participate in the project as Collaborators. Collaborators are those scientists not requesting OIRM funds; please note OIRM funds must remain within the province of Ontario.

A single PDF file with CVs of all investigators requesting funding from OIRM is required. Pleases use the CIHR Canadian Common CV format. For the publications section, only list up to 25 selected publications (relevant to the proposal), the presentation section of the CCV is not required. CVs for Collaborators (i.e. those not requesting funds) and Highly Qualified Personnel do not need to be submitted.

Table 1. OIRM Investigators (OIRM Investigators requesting funds from OIRM)Name Position & Institution Phone & Email1.Role in project:

2.Role in project:

3.Role in project:

* Please insert rows as required.

Table 2. Collaborators (Canadian & International Collaborators not requesting funds from OIRM)Name Position & Institution Phone & Email1.Role in project:

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

2.Role in project:

3.Role in project:

* Please insert rows as required.

Table 3. Highly Qualified Personnel (including: Undergraduate, Graduate Student, Postdoctoral Fellow, Research/Scientific Associate, Technician)Name Position & Institution Phone & Email1.Role in project:

Will this HQP be funded fully, partially or not by this grant:2.Role in project:

Will this HQP be funded fully, partially or not by this grant:3.Role in project:

Will this HQP be funded fully, partially or not by this grant:* Please insert rows as required.

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

3. RESEARCH PROPOSAL

In ten (10) pages maximum (including tables and figures but not references):

a) Describe the background, rationale, and objectives of the projectb) Outline the proposed research methods and approach, clearly demonstrating the

integration of project members’ expertise towards achieving the goals of the projectc) Detail the anticipated key milestones for each of the three funded years and the key

deliverables anticipated by the end of funding period (Mar 14/21), highlighting how they have a commercial and/or clinical impact

d) Identify potential project pitfalls and alternative approaches that will allow for the continued success of the project

e) Highlight the international competitiveness of the project, clearly articulating why this approach and this team is internationally competitive

f) Provide up to 30 references maximum at the end of the proposal that are directly relevant to the project

g) For Disease Team awardees funded in 2017-2018, please provide an additional one page progress report on milestones, following the research proposal

The application format should use single spaced, Calibri (minimum size 12) font, with 1-inch margins, please include page numbers on the research proposal. Use of timelines and tables to describe the project design are highly recommended, especially where parallel studies are described.

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

4. PARTNERSHIPS

Each application must demonstrate an ability to coordinate the funding required ensuring the success of the project. Partnerships are mandatory and high quality partnerships will yield an increased ranking of the application. OIRM will work with grant awardees throughout the duration of the project to secure additional funding to support the project.

Please provide a letter of support on the letterhead of each eligible partner detailing the extent of their collaboration and/or their cash and/or in-kind contribution towards the particular project. Please add a dollar value to all in-kind contributions. This should include Matched Funding (any funding directly associated with this project) and Existing Leveraged Funding (ongoing sources of related funding). Letters of support are not required for Future Potential Sources of Matched Funding. The letters should specifically include reference to the proposed project and any conditions placed on funding. Please submit the partner letters of support in one PDF as Document 3 of the application package (detailed on page 1), please indicate in the table below the page number of each associated letter of support.

In the three tables below, please list each potential partner, the specific nature of the contribution, and the cash and/or in-kind contributions anticipated from the partner(s) to the project. Where a researcher has a “financial interest” in a partner, the potential conflict of interest should be declared. This does not preclude the partnership in any way, but provides transparency to the review process.

Matched Funding

Please list all matching funds directly associated with this project for the funding period (March 15/18 to March 14/19). Matching funds can be from granting agencies, foundations, health charities, philanthropy or industry. Please include all details as listed below for each funding source. A letter of support is REQUIRED for each listed fund and must show details outlined in 5 bullets below.

Name of Receptor/Partner Nature of contribution (Cash and/or in-kind)

Contribution (CA$)

1.Role in project:

Potential conflict of Interest:

Page number of associated letter of support:

Fund details (must be completed):1. Funding source:2. Title of project that this funding supports:

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

3. Lead PI on this project:4. Amount of funding per year (if different each year, please clarify):5. Funding period (MM/YR to MM/YR):

2.Role in project:

Potential conflict of Interest:

Page number of associated letter of support:

Fund details (must be completed):1. Funding source:2. Title of project that this funding supports:3. Lead PI on this project:4. Amount of funding per year (if different each year, please clarify):5. Funding period (MM/YR to MM/YR):

3.Role in project:

Potential conflict of Interest:

Page number of associated letter of support:

Fund details (must be completed):1. Funding source:2. Title of project that this funding supports:3. Lead PI on this project:4. Amount of funding per year (if different each year, please clarify):5. Funding period (MM/YR to MM/YR):

* Add more rows if necessary.

Existing Leveraged Funding

Please list ongoing sources of associated funding for this funding period (Mar 15/18 to Mar 14/19). Potential sources include granting agencies, foundations, health charities, philanthropy or industry. As Lead PI your salary (10% of salary,) and that of Co-Investigator salaries (5% of salary), and institutional indirect costs (40% of OIRM grant funding you are requesting) are not eligible budget items, and should be listed here as in-kind institutional support as leveraged funding.

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

The actual dollar value should be indicated in both the tables below as well as letters of support from the institution. OIRM is required to collect salary information from investigators for reporting purposes. All salary information will be kept confidentially within OIRM and not made available to reviewers.

A letter of support is REQUIRED for each listed fund (including salaries and institutional indirect costs) and must show details outlined in 5 bullets below.

Name of Receptor/Partner Nature of contribution (Cash and/or in-kind)

Contribution (CA$)

1.Role in project:

Potential conflict of Interest:

Page number of associated letter of support:

Fund details (must be completed):1. Funding source:2. Title of project that this funding supports (for salary support, list title as professor, clinician

etc.):3. Lead PI on this project:4. Amount of funding per year (if different each year, please clarify):5. Funding period (MM/YR to MM/YR):

2.Role in project:

Potential conflict of Interest:

Page number of associated letter of support:

Fund details (must be completed):1. Funding source:2. Title of project that this funding supports (for salary support, list title as professor, clinician

etc.):3. Lead PI on this project:4. Amount of funding per year (if different each year, please clarify):5. Funding period (MM/YR to MM/YR):

3.Role in project:

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

Potential conflict of Interest:

Page number of associated letter of support:

Fund details (must be completed):1. Funding source:2. Title of project that this funding supports (for salary support, list title as professor, clinician

etc.):3. Lead PI on this project4. Amount of funding per year (if different each year, please clarify):5. Funding period (MM/YR to MM/YR):

* Add more rows if necessary.

Fund details sample from grant agency:1. Funding source: CIHR2. Title of project that this funding supports: Cure for diabetes.3. Lead PI on this project: John Smith4. Amount of funding per year (if different each year, please clarify): Yr1: $150K, Yr2: $150K,

Yr3: $200K5. Funding period (MM/YR to MM/YR): April 2015 to March 2018

Fund details sample from facilities/infrastructure support or an endowed chair/Canada Research Chair: 1. Funding source: Endowed Chair2. Title of project that this funding supports: Jones Family Endowed Chair in Endocrinology3. Lead PI on this project: Joan Adams (i.e. Person receiving support)4. Amount of funding per year (if different each year, please clarify): 100K per year5. Funding period (MM/YR to MM/YR): May 2016 to March 2020

Future Potential Sources of Matched FundingPlease identify additional funding sources that may be available to support this project if OIRM funds are granted in this competition, including industry, venture capital investment, philanthropy, foundations, health charities or granting agencies. Letters of Support are not required for these projected partnerships.

Name of Receptor/Partner Nature of contribution (Cash and/or in-kind)

Contribution (CA$)

1.Role in project:

Potential conflict of Interest:

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

2.Role in project:

Potential conflict of Interest:3.Role in project:

Potential conflict of Interest:* Add more rows if necessary.

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

5. TRANSLATION AND COMMERCIALIZATION (2 pages max)

Describe where the project is situated in the translational pipeline, how the outcomes of the project will be used in the next phase, and at a high level, the likely timeframes and next steps for moving therapies or technologies into practice and bringing the technologies to market. OIRM understands that not all items below will be completed within the 2-year funding period but wants investigators to demonstrate a long-term plan for accomplishing all required steps for translation, including use of appropriate partners to ensure success. Describe the specific strategies that will be employed, beyond publications, to translate the technologies from this project, including:

Patent and intellectual property management1; Technology and manufacturing scale-up for clinical grade and quantity1 and 2; Regulatory approval1 and 2(Clinical Trial Application, Health Canada); Clinical trials expertise2 (trial design and protocol, REB, DSMB, screening and

recruitment, data management, monitoring, reporting, site management etc.); Industry receptors and/or out-licensing and company creation1; Development of a reasonable reimbursement model1 and 2; Engagement of the clinical community for future adoption of technology or therapy2.

Describe the role of existing partners in realizing each of these goals and the likely future partners that will be needed in due course.

1CCRM is available to assist with these items. If you want to book a consultation with CCRM, please do so by September 1/17 by contacting Mira Puri <mira.puri@ccrm.ca>

2OIRM can provide connections to institutional clinical trial support units/in-house Clinical Research Organizations, OIRM investigators experienced in these areas and clinical leaders in OIRM’s disease areas of focus. Please contact sandra.donaldson@oirm.ca for more info.

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

6. PATIENT ENGAGEMENT / PUBLIC OUTREACH (1/2 page max)

Please describe appropriate patient engagement /public outreach activities your team will be involved within the context of your disease area of focus. If partnerships with health charities are already in place or about to start, this could include public speaking at the charity’s event and/or acting as a resource for patient education programs. Participation in institutional foundation activities is also acceptable. If you do not have a current health charity partnership, OIRM may request you to participate in these activities with a health charity or other applicable organization related to your disease area of focus.

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

7. BUDGET

Please complete the Excel budget template and provide justification/comments to the budget below. Indirect costs, PI or Investigator salaries are not eligible expenditures but should be listed as institutional in-kind support (PI salaries at 10%; Co-Investigator salaries at 5%, and indirect costs at 40% of OIRM requested funding). Up to $10,000/year is allowed for travel expenses associated with OIRM Clinical Trial Initiative workshops, OIRM Symposium and Rounds, and other related OIRM events. Travel funds cannot be used for travel to conferences or other events not organized by OIRM. Please request the OIRM travel policy guidelines from jodi.garner@oirm.ca if needed.

Justification and CommentsProvide justification/comments to your budget below (5 page limit). Identify items by noting the Excel spreadsheet row number relevant to the item. Please also include sources, details and amounts for first year of funding.

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Disease Team Grant Application 2018-2019Name of Principal Investigator:

8. PROJECT MANAGEMENT

OIRM will provide a central project manager who will work with the Principal Investigator to assist with tracking of milestones for the duration of the grant. Aside from the PI, please list below a secondary person within the team who is available (and readily accessible) to assist with updating project management milestones (preferably senior members including Postdoctoral Fellow, Research/Scientific Associate or Lab Manager).

Name:

Position:

Institution:

Email address:

Phone Number:

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