January 7, 2025
November 06, 2024 - Assay development and screening for discovery of chemical probes, drugs or immunomodulators (R01 Clinical Trial Not Allowed). See NOFO PAR-25-153.
National Cancer Institute (NCI)
The purpose of this Notice is to correct the instructions for two areas of the Research Strategy in Section IV (Application and Submission Information) of PAR-25-153 “Assay development and screening for discovery of chemical probes, drugs or immunomodulators (R01 Clinical Trial Not Allowed)”.
Section IV. Application and Submission Information
Part 2. Content and Form of Application Submission
Research Plan
Research Strategy: Applicants should address the following topics as they pertain to the proposed research project:
Importance of the Research (Significance and Innovation): Applicants should address why the chosen target or pathway is significant for the proposed chemical probe/drug discovery project, and whether the probe will provide new insight into important cancer targets and processes. Preliminary data or published information demonstrating the significance of the target or pathway should be included. Any existing modulators for the target should be mentioned, and a rationale for doing additional development of small molecules that address the target should be delineated.
Modified to Read (in bold italics)
Research Strategy: Applicants are encouraged to address the following topics as they pertain to the proposed research project:
Importance of the Research (Significance and Innovation): Applicants are encouraged to address why the chosen target or pathway is significant for the proposed chemical probe/drug discovery project, and whether the probe will provide new insight into important cancer targets and processes. Preliminary data or published information demonstrating the significance of the target or pathway should be included if available. Existing modulators for the target should be mentioned, and a rationale for doing additional development of small molecules that address the target should be delineated. Because the focus of this NOFO is on development of screens and/or identification of probes or drugs for known cancer target(s), hypothesis-driven or mechanistic specific aims are not expected.
2. Currently Reads
Critical path: The application should include a flow diagram to outline all critical steps in sequential and/or parallel manners with appropriate benchmarks and timelines for whichever stage(s) of discovery are proposed. The flow diagram may include but is not limited to: the primary assay to be implemented or previously implemented; alternative assay or approach (e.g., computational docking) to ensure success of the screening; hit selection criteria; cheminformatic analysis; chemical tractability assessment; all follow-up assays to validate screening hits; and assay responsibilities of each party involved in the project.
Modified to Read (underlined)
Critical path: The application should include a flow diagram to outline all critical steps in sequential and/or parallel manners with appropriate benchmarks and timelines for whichever stage(s) of discovery are proposed. The flow diagram may include but is not limited to: the primary assay to be implemented or previously implemented; alternative assay or approach (e.g., computational docking) to ensure success of the screening; hit selection criteria; cheminformatic analysis; chemical tractability assessment; all follow-up assays to validate screening hits; and assay responsibilities of each party involved in the project. By its nature, drug discovery is a sequential process; therefore, dependent specific aims are allowed.
Please direct all inquiries to:
Suzanne Forry, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5922
Email: forryscs@mail.nih.gov