ISHLT Innovation Challenge Grant

CareDx Supported By: CareDx

This grant supports investigation that tests the utility of the combination of donor-derived cell-free DNA (dd-cfDNA) and gene expression profiling (GEP) in heart transplantation, or the utility of dd-cfDNA in lung transplantation. Winning research will focus on how these noninvasive tools improve outcomes for transplant recipients. Proposals that aim to determine if these tools can improve outcomes through immunomodulation or guiding rejection treatment are also encouraged. The award is designed to support researchers at academic institutions who are also active members of ISHLT.

After the application period, selected finalists will be invited to present their research proposal at a specialized session at the ISHLT 2022 Annual Meeting and Scientific Sessions to take place in Boston, MA, USA from 27-30 April, 2022, where the winner will be determined by a panel of on-site judges.

Purpose

The purpose of this grant is to support transplantation and immunology research by testing the utility of donor-derived cell-free DNA (dd-cfDNA), gene expression profiling, or the combination thereof for heart or lung transplant recipients.

Grant Details

One grant will be bestowed annually in an amount of up to $15,000.

Research Priorities
This grant will fund research that tests the utility of the combination of donor-derived cell-free DNA (dd- cfDNA) and gene expression profiling (GEP) in heart transplantation, or utility of dd-cfDNA in lung transplantation. The research will focus on how these noninvasive tools improve outcomes for 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. Another genomic medicine technique for monitoring allograft function is gene expression profiling (GEP) of peripheral blood. GEP characterizes changes in gene expression (upregulation and downregulation of genes) that identify pathologic states. GEP and dd-cfDNA, separately and in combination, show 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 such noninvasive tools for allograft surveillance through improved outcomes, reduction in mortality and morbidity to patients, increased graft survival, improved quality of life and reduced costs to the health system. There is also scope for genomic medicine to guide immunosuppression and rejection treatment. Proposals that aim to determine if these tools can improve outcomes through immunomodulation or guiding rejection treatment are also encouraged.
Eligibility Requirements
Academic Appointment and Institutional Resources
  1. The applicant must have an academic appointment at an accredited institution of higher learning.
  2. An individual may apply for the research grant while still in training. However, they must have been offered and accepted a faculty position that will begin on or before initiation of the grant.
ISHLT Membership
  1. The applicant must be an active member of ISHLT or have submitted a completed membership application by the grant deadline.
Previous ISHLT Funding/Funding from Other Sources
  1. There are no restrictions on past or current funding.
  2. The applicant may be a past or current recipient of an ISHLT Fellowship or Faculty Development research grant.
  3. The applicant may currently hold career development awards, mentoring awards, or other independent research awards.
  4. If the applicant is currently receiving funding for a project similar to the topics described in this RFA, the applicant should explain how the funds of the grant would not overlap with the funds of the other research support.
Miscellaneous
  1. 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.
Funding Stipulations / Grant Policies
  1. Research must begin on 1 July of the grant year and end by 30 June of the following year. The research start date cannot be deferred.
  2. Funding in the amount of $15,000 will be provided for the research project.
  3. Funding will not be released until visa status is confirmed (if applicable).
  4. The grant is intended to provide only salary support for the researcher, supplies/materials, and statistical analysis support. No other costs are permitted, including institutional overhead.
  5. 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 6 months later (after receipt of a grant progress report) and the final installment (25%) will be paid after receipt of a final report.
  6. Grant funding is not transferable from one recipient to another. If the grantee relocates, the ISHLT 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; see item 9 below.
  7. 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 for Heart and Lung Transplantation.” Copies of such publications must be submitted to ISHLT.
  8. 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.
  9. 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:
    • Six-month progress report due 1 January.
    • 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.
Review Process and Notification
  • Decisions for finalist positions will be made by an expert review committee from ISHLT. Grants will be scored on the basis of novelty, 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 their application has been accepted as a finalist for presentation by 15 March.
  • Finalists will then be expected to present their proposed research project to the expert review committee live at the ISHLT Annual Meeting. From these finalists the expert review committee will select the project and investigator that will receive the grant
  • For the selected individual, the term of the grant will begin 1 July.

Current Recipient