Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

National Cancer Institute (NCI)

Purpose

As part of the Cancer Moonshot initiative, the National Cancer Institute (NCI) created the Patient-Derived Xenograft (PDX) Research Network (PDXNet), a collaborative network of U54-funded PDX Development and Trial Centers (PDTCs) of excellence coordinated by a U24-funded PDXNet Data Commons and Coordinating Center (PDCCC) focused on using patient-derived xenografts and other patient-derived models to accelerate the development of NCI investigational new drug (IND) agents (i.e., those that the NCI is developing in collaboration with pharmaceutical partners) in NCI-sponsored early phase clinical trials. Because PDXNet investigators have valuable models and specialized expertise not usually accessible to most investigators, NCI through this Notice of Special Interest (NOSI) intends to make the resources of these centers available to other investigators to test novel therapeutic concepts.

Research Objectives

This NOSI will support supplemental funds to current NCI-funded research projects in PDXNet for new interdisciplinary collaborations between PDXNet investigators and non-PDXNet investigators. Non-PDXNet investigators include physician scientists in NCI-funded clinical trials networks. These collaborations should perform research within the scientific scope(s) of the cooperative agreement award, to include pre-clinical evaluations of novel therapeutic concepts using the large-scale PDX model collections of PDXNet for translation into clinical trial concepts. This request for administrative supplements supports NCI’s efforts to enhance the development of PDX models as a tool for precision medicine that will guide cancer drug development and cancer therapy. The research project proposed in the administrative supplement should align with the overarching goal of the PDXNet, which is to develop pre-clinical data to support novel therapeutic concepts that have a feasible path for clinical validation.

Responsiveness

1. Applicants submitting administrative supplement requests in response to this NOSI must be a PDXNet investigator funded through RFA-CA-17-003 or RFA-CA-17-032
2. Must propose a collaboration with a non-PDX investigator

A subcontract award from the PDXNet investigator’s institution may be used to fund research conducted by the non-PDXNet collaborating investigator under this administrative supplement. A collaboration that involves a subcontract should describe research performed by both the collaborator and the PDXNet investigator. The non-PDXNet collaborator may commit to translating the research results into a clinical trial concept based on the data generated under the supplement award should these data be supportive of the concept.

Applicants are encouraged to discuss their application with the scientific/research contact listed in this NOSI prior to submission.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Eligibility and Eligible Individuals (Program Director/Principal Investigator): Applicant(s) must be a PDXNet investigator.
• Application Due Date: All requests, regardless of the parent award funding mechanism, must be received by 5:00 PM local time on March 1, 2022, for possible funding in FY 2022. This NOSI will expire on March 2, 2022.
• Budget: FY 2022 supplement budget requests cannot exceed $200,000 in total costs. Requests must reflect the actual needs of the proposed project. Administrative supplements can be used to cover cost increases that are associated with achieving certain new research objectives as long as the research objectives are within the original scope of the peer-reviewed and approved project (i.e., award), or the cost increases are for unanticipated expenses within the original scope of the project. If the non-PDXNet collaborator is to be funded utilizing a subcontract to the parent award, the budget of the collaborating non-PDXNet investigator should be included in the budget section of the administrative supplement request.
• Requests: permitted for 1 year of support only. The earliest anticipated start date is May 2,2022. NCI intends to commit $1,500,000 in FY 2022 to fund up to 7 awards.

Submitting Applications:

• For administrative supplements to grants and cooperative agreements, supplement requests must be submitted in accordance with the parent program announcement, PA-20-272. NOTE: Administrative supplement requests (applications) for support of clinical trials will not be accepted and/or considered in response to this NOSI.
• Applicants should begin the supplement application abstract by stating “This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA-22-039.”
• Supplement requests should be submitted electronically.
• For funding consideration, applicants must include “NOT-CA-22-039” (without quotation marks) in the Agency Routing Identifier field (box 4b) of the SF424 R&R form. Applications without this information in box 4b will not be considered for this initiative.
• In order to facilitate efficient processing of the request applicants are strongly encouraged to notify Kim Witherspoon (kw265c@nih.gov), as well as the assigned NCI Program Official for the parent award that a request has been submitted in response to this NOSI.
• A letter of support written and signed by the collaborating non-PDXNet collaborator is required. Use the “Add Other Attachments” function to electronically include the letter of support in PDF format. This support letter should corroborate the nature of the collaborative effort, as outlined in the application, and reiterate the specific work that will be done by the U54 PDTC group.
• Page Limits – These sections have the following limits:
  • Project Summary/Abstract: 30 lines of text
  • Project Narrative: 3 sentences
  • Research Strategy: 12 pages
  • Biographical Sketch: for Senior/Key Personnel and Significant Contributors only
• The application submitted in response to this NOSI (i.e., the administrative supplement request/application) should include a figure or table in the Research Strategy section that outlines the plans for work to be performed by the non-PDXNet collaborator and the work to be performed by the PDXNet or Minority PDXNet collaborating U54 award. A graphic representation of the collaborative interaction between the applicant and the PDXNet collaborator is encouraged. The chosen approach should clearly separate the work that is planned for performance by the collaborator from that proposed for performance at the specified PDTC. The application should clearly show how the work planned for performance by each of the partners (i.e., by the collaborator and by the PDTC) is intended to be collaborative.

Review and Selection Process

NCI will conduct administrative reviews of applications and will support the most meritorious applications submitted for consideration, based upon availability of funds. Additionally, Program staff will evaluate applications using the following selection factors.

NIH staff will consider the ability of the proposed supplement activities to increase or preserve the PDXNet award’s overall impact within the original scope of the award, including the degrees to which the administrative supplement request (application):

• Tests therapeutic concepts using the large-scale PDXNet model collections, especially concepts that require identification of molecularly defined subsets of histologically defined tumors

• Identifies potential biomarkers that could be used to monitor or select patients for therapy

• Identifies underlying genetic or epigenetic variations that could explain different therapeutic responses between racial/ethnic minority patient populations (if applying for a Minority-PDTC collaboration)

• Outlines an interactive collaboration between the PDXNet investigator and the non-PDXNet investigator

Inquiries

Please direct all inquiries to:

Kim Witherspoon
National Cancer Institute (NCI)
Telephone: 240-276-6141
Email: kw265c@nih.gov

Jeffrey Moscow, M.D.
PDXNet Program Official
National Cancer Institute (NCI)
Telephone: 240-276-6565
Email: jeffrey.moscow@nih.gov

Tiffany Wallace, Ph.D.
M-PDTC Program Officer
National Cancer Institute (NCI)
Telephone: 240-276-5114
Email: Tiffany.Wallace@nih.gov