## Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Not Allowed)**1. Overview****1.1 Funding Opportunity Title:** Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Not Allowed)**1.2 Funding Opportunity Number:** PAR-25-338**1.3 Brief Program Description:** The purpose of this Notice of Funding Opportunity (NOFO) is to stimulate efforts to translate scientific discoveries and engineering developments into methods or tools that address problems in basic research to understand disease, or in applied research to assess risk, detect, prevent, diagnose, treat, and/or manage disease. The rationale is to deliver new capabilities to meet evolving requirements for technologies and methods relevant to the advance of research and delivery of care in pre-clinical, clinical and non-clinical settings, domestic or foreign, for conditions and diseases within the missions of participating institutes.**1.4 Key Dates:*** Letter of Intent Due Date(s): **Optional, See Funding Opportunity*** Application Due Date(s): **February 05, 2025, June 05, 2025, October 05, 2025, February 05, 2026, June 05, 2026, October 05, 2026, February 05, 2027*** Earliest Start Date: **December 31, 2024****1.5 Amount Available:** Not Specified**1.6 Application and Submission Information:*** Application Submission Deadline: **5:00 PM local time of applicant organization*** Submit electronically via the online portal at Grants.gov (www.grants.gov)* All applications are due by 5:00 PM local time of applicant organization on the application due date(s) listed in the Funding Opportunity Announcement (FOA) and Grants.gov system. Applications submitted after this time will not be accepted and will be considered late.**1.7 Funding Restrictions:** Standard NIH restrictions apply.**1.8 Eligibility Information:** * Non-domestic (non-U.S.) and domestic (U.S.) entities (Foreign organizations; Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education); Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education); Small Businesses; For-Profit Organizations (Other than Small Businesses); and State Governments) are eligible to apply. * Applications submitted by foreign organizations must be submitted through the NIH Office of Global Health Research (OGHR). * Applications from foreign organizations that have not received a DUNS number may use the DUNS number assigned to the OGR, which is 042765015.**1.9 Important Notice:** The funding opportunity described in this NOFO is available through a number of companion funding opportunity announcements, including PAR-25-337. It is important to note that applications may only be submitted to one of these companion announcements. Submitting the same application to more than one FOA may result in both applications being considered ineligible for review.**1.10 Federal Opportunity Number:** Not Specified**1.11 Program Report Submission**: **Not Applicable****1.12 Assistance Listing Number:** Not Specified **1.13 Special Notice**: **Not Applicable****2. Funding Opportunity Description****2.1 Program Description:** **Introduction**The National Institutes of Health (NIH) invites applications for research projects to enhance, adapt, optimize, validate, and otherwise translate a technology, method, assay, device, or system from a demonstration of possibility to a status useful in pre-clinical, clinical or non-clinical research settings. Technological improvements may focus on reproducibility, reliability, rapidity, ease of use, or affordability.Partnerships of academics and their affiliated start-up technology companies are allowable so long as financial conflicts of interest will be managed in compliance with Department of Health and Human Services and National Institutes of Health policy as described in 42 CFR part 50. The level of participation and budget details are expected to vary among the partners as necessary to achieve the specific translational research goals proposed. The strategic alliance is expected to combine research strengths, laboratory, and other resources unique to each group to advance the translational research goal. Industrial involvement from the beginning is expected to facilitate more efficient transfer of intellectual property to the commercial setting. For example, it is likely final outcomes would improve if the investigators chose from the start to adopt industry's focus on manufacturability and reliability. For clinically oriented projects, routine use of good laboratory practices (GLP) and good manufacturing practices (GMP) would reduce risk and raise the likelihood of meeting FDA standards and consumer expectations. Commercialization of the proposed technologies would be the usual goal, but is not necessarily the only path to sustainable dissemination that is a critical objective of this NOFO.This NOFO will support work up to the point of pre-commercial production, but specifically does not support commercial production.Technology translation to solve a target problem may focus on clinical research, clinical care delivery, or non-clinical research. Technological improvements may focus on reproducibility, reliability, rapidity, ease of use, or affordability.**Partnerships of academics and their affiliated start-up technology companies are allowable so long as financial conflicts of interest will be managed in compliance with Department of Health and Human Services and National Institutes of Health policy as described in 42 CFR part 50.** The Level of participation and budget details are expected to vary among the partners as necessary to achieve the specific aims proposed. The strategic alliance is expected to combine research strengths, laboratory, and other resources unique to each group to advance the translational research goal. Industrial involvement from the beginning is expected to facilitate more efficient transfer of intellectual property to the commercial setting. For example, it is likely final outcomes would improve if the investigators chose from the start to adopt industry's focus on manufacturability and reliability. For clinically oriented projects, routine use of good laboratory practices (GLP) and good manufacturing practices (GMP) would reduce risk and raise the likelihood of meeting FDA standards and consumer expectations. Commercialization of the proposed technologies would be the usual goal, but is not necessarily the only path to sustainable dissemination that is a critical objective of this NOFO.This NOFO will support work up to the point of pre-commercial production, but specifically does not support commercial production.**Research Objectives**Key parties are expected to participate from the beginning. The academic-industrial partnership may include any number of participants and organizations necessary to assemble a critical mass of expertise and know-how for effective execution. The level of participation is expected to vary among the partners as necessary to reach the specific translational research goals proposed. The strategic alliance is expected to combine research strengths, laboratory, and other resources unique to each group to advance the translational research goal. Industrial involvement from the beginning is expected to facilitate more efficient transfer of intellectual property to the commercial setting. For example, it is likely final outcomes would improve if the investigators chose from the start to adopt industry's focus on manufacturability and reliability. For clinically oriented projects, routine use of good laboratory practices (GLP) and good manufacturing practices (GMP) would reduce risk and raise the likelihood of meeting FDA standards and consumer expectations. Commercialization of the proposed technologies would be the usual goal, but is not necessarily the only path to sustainable dissemination that is a critical objective of this NOFO.This NOFO will support work up to the point of pre-commercial production, but specifically does not support commercial production.**Technology translation to solve a target problem may focus on clinical research, clinical care delivery, or non-clinical research. Technological improvements may focus on reproducibility, reliability, rapidity, ease of use, or affordability.Concept of Innovation: Invention as likelihood to deliver new capability: **innovation as likelihood to deliver a new capability to end users**. Capability is defined by any technology, method, or tool designed to detect/measure/correct/predict some clinical or physiological issue(s). If the proposed project succeeds, it should produce a new device or enable a novel approach to an issue in clinical research, diagnostics, monitoring, or the attendant procedures.The goal of this NOFO is to take technologies with proof-of-principle for their approach to a specific issue, and take them through the necessary steps needed to translate that ingenuity into a product of widespread clinical use. This NOFO seeks to fund projects up to 5 years in length, with a specific target problem placed at the heart of each research effort.Possible technologies designed to address a targeted problem as defined in this NOFO include, but are not limited to:* Development, integration and validation of new molecular diagnosis, imaging or spectroscopy systems, technologies, methods, assays, or devices, related component technologies, molecular diagnostic technology, image processing methods, and development of informatics tools; for example, non-stain molecular contrast methods for pathology slide microscopy, such as molecular bond vibrational spectroscopic imaging maps.* Implementation of research methods on one version or multiple manufacturer's versions of commercial platforms, where appropriate;* Harmonization of data collection and data analysis across single and/or different commercial platforms to reduce the sources of uncertainty in use of biomarkers or other research areas as required for multi-site preclinical or clinical investigations; these efforts may include development of open computer platforms and open source software tools.* Development of shared resources, data archives, and other approaches intended to facilitate consensus methods for optimization and validation of emerging technologies and methods; it is understood that many commercial entities develop open source tools to support validation of technologies and such applications are encouraged.* Applications appropriate for this NOFO require the following attributes