Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Not Allowed)
Funding Agency:
- National Institutes of Health
The rationale of this NOFO 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. This NOFO specifies a partnership structure expected to help bridge gaps in investigator knowledge and experience by engaging the strengths of academic, industrial, and other investigators. They are expected to plan, design, and solve a problem, and validate it as suitable for end users.
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.
Partnerships of academics and their affiliated start-up technology companies are allowable so long as financial conflicts of interests 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 investigators have the discretion to set effort levels and apportion budget according to the timing and other project requirements at each research step.
Each academic-industrial partnership is encouraged to solve its targeted problem within the funding period. This NOFO will support the placement of copies of prototypes in multiple research sites for study and validation of performance.
Possible technologies designed to address a targeted problem as defined in this NOFO include, but are not limited to, the following:
- 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:
- Contain research partnerships formed by academic and industrial investigators, and any other participants to assure the group has a critical mass of essential skills and know-how to perform the translational aims proposed;
- Propose to enhance, adapt, optimize, validate, and otherwise translate a technology, method, assay, device, or system for diagnosis, imaging or spectroscopy for (a) current commercially supported system, (b) next-generation system, (c) quality assurance and quality control, (d) validation and correlation studies, (e) quantitative methods, (f) related research resource, or (g) other possibilities;
- Propose to mitigate or solve a targeted problem in risk assessment, detection, diagnosis, staging, treatment, and/or treatment monitoring;
- Propose to accomplish substantial progress toward delivery of their translated product as a new capability for use by end users in pre-clinical, clinical research or clinical care;
- Propose to develop or adapt a technology for a low resource setting or underserved population.
Application budgets are limited to $499,000 (direct costs) per year.
February 05, 2025; June 05, 2025
Miguel R. Ossandon, Ph.D. (he/him/his)
National Cancer Institute (NCI)
Telephone: 240-276-5714
Email: ossandom@mail.nih.govv
Darrell Tata, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3315
Email: Darrell.tata@nih.gov
Rao L. Divi, Ph.D.
National Cancer Institute, NIH
Phone: (240) 276 6913
Email: divir@dc37a.nci.nih.gov