Noninvasive Biomarker Research on Lung Transplant Patient Care with Donor-Derived Cell-Free DNA Grant
Supported By:
CareDx
The grant will fund research that tests the utility of donor-derived cell-free DNA (dd- cfDNA). The research will focus on the utility of dd-cfDNA to measure of allograft injury and detect rejection for lung transplant recipients.
Although rates of acute rejection have declined after solid organ transplantation, there is an unmet need to better define the molecular phenotype of rejection and provide non-invasive, precision medicine tools to better detect rejection. The standard-of-care for detecting allograft rejection is pathology-read biopsy, which suffers from sampling error, interobserver variability, and artefacts that result in often subjective and varying diagnoses of allograft rejection. Genomic medicine, including biomarkers such as donor-derived cell-free DNA, may permit non-invasive and earlier detection of allograft injury and rejection, and may allow for quantitative serial monitoring of graft health and response to rejection treatment. dd-cfDNA shows potential utility for monitoring allograft health and identifying graft injury sooner and more accurately than the standard-of-care. We seek investigators who will test the value of dd-cfDNA for allograft surveillance through improved outcomes, reduction in mortality and mobility to patients, increased graft survival, improved quality of life and reduced costs to the health system. There is also scope for non-invasive tools to guide immunosuppression and rejection treatment. Proposals that aim to determine if dd-cfDNA can improve outcomes through immunomodulation or guiding rejection treatment are also encouraged.
Purpose
The purpose of this grant is to fund research that supports transplantation and immunology research by testing the utility of donor- derived cell-free DNA (dd-cfDNA) for lung transplant recipients.
Grant Details
Two grants will be awarded for the funding duration of one year. The budget for each grant will be up to $40,000. One grant will be designated for research to be performed in a laboratory located in the United States, and one grant will be designated for research to be performed in a laboratory located outside the United States.
- The applicant must have an academic or clinical appointment or may be in training at an accredited institution.
- An individual who applies for a research grant while still in training must have been offered and accepted a faculty position that will begin on or before initiation of the grant or submit a letter of institutional commitment from a division or department chair at their institution.
- The applicant must be an active member of ISHLT or have submitted a completed membership application by 29 September, 2023.
- There are no restrictions on past or current funding.
- The applicant may be a past or current recipient of ISHLT funding including Fellowship or Faculty Development research grants.
- The applicant may currently hold career development awards, mentoring awards, or other independent research awards.
- If the applicant is currently receiving funding for a project similar to the topics described in this request for applications, the applicant should explain how the funds of the grant would not overlap with the funds of the other research support.
- Applicants who have a substantial relationship with CareDx that would present a real or perceived conflict of interest if awarded this grant must first contact ISHLT to declare the conflict before submitting an application. Examples of a substantial relationship with an industry partner include board member, member of advisory council, consultant, lecturer, etc.
- Employees of CareDx cannot submit an application.
- Upon disclosure, the Grants and Awards Committee will determine if the individual is eligible to submit an application and will notify the individual in a timely manner.
Please review these guidelines and terms prior to completing your application. If you are ultimately awarded a grant, you will sign a letter of agreement (LOA) stating that you agree to these funding guidelines and terms, and the LOA will be co-signed by your institution’s grants/research office.
- Research is anticipated to begin between January and December of the grant year.
- Funding in the amount of $40,000 will be provided for one year of research.
- Funding will not be released until visa status is confirmed (if applicable).
- The grant is intended to provide salary support for the researcher, other study personnel, statistical support, supplies/materials, animals, publication costs and travel related costs for abstract presentation and up to 10 percent of the grant can be used for institutional overhead. No other costs are permitted.
- The grant will be paid in multiple installments to the recipient’s institution. First installment (50% of funds) will be paid at the beginning of grant work; the second installment (25%) will be paid mid-award (after receipt of a grant progress report) and the final installment (25%) will be paid after receipt of a final report.
- Grant funding is generally not transferable from one recipient to another; transfer may be considered under compelling circumstances (e.g., the grantee leaves the institution and does not request a transfer of the grant, or the grantee requires an extended medical leave).
- If the grantee relocates and requests to move the grant to the new institution, the ISHLT Grants and Awards Committee will determine if the grant can be transferred to the recipient’s new location, or if the grant must be surrendered and any remaining funds returned. If the grant is surrendered, a final report will still be required.
- The applicant must acknowledge the grant as a funding source in all manuscripts and presentations derived from the funded research using the following statement: “This work was supported by a grant from CareDx and the International Society of Heart and Lung Transplantation.” Copies of such publications must be submitted to ISHLT.
- Pursuant to regulations of the federal Physician Payment Sunshine Act (included in the Affordable Care Act), NPI numbers will be collected from grant recipients (if applicable), and tax ID numbers collected from the recipients’ institutions (if applicable). All payments will be reported to the Centers for Medicare and Medicaid Services Open Payments system, as payments from ISHLT represent indirect transfers of value from the funding pharmaceutical company.
- Reports are required at the following intervals depending on the term of the grant, and continuation of funding is contingent upon completion of these reports:
- Mid-award progress report due six months after research start date.
- Final report within 30 days of the conclusion of the grant term.
- A final report is required even if the grant is surrendered for any reason prior to the conclusion of the grant term.
- Selection of the grant recipient will be made by an expert review committee. The Grants and Awards Committee will work with the Interdisciplinary Networks and Professional Communities to identify the experts who will review the applications. In case of a very close or tie scores, the ISHLT Grants and Awards Committee will make the final decision. Consultation from expert reviewer(s) may be requested.
- Grants will be scored on the basis of study aims, significance, innovation, research approach, feasibility of obtaining relevant data, and prior work, as well as other factors.
- All applicants will be notified as to whether or not they have been selected to receive the research grant by 15 November
- For the individual selected, the term of the grant will be one year beginning between January – December of the grant year.
