The Duke Funding Alert newsletter, published every Monday, provides information on all new and updated grants and fellowships added to the database during the prior week. This listserv is restricted to members of the Duke community.
Emergency Awards: HEAL Initiative: Translational Science Career Enhancement Awards for Early and Mid-career Investigators (K18 Clinical Trials Not Allowed)
NCATS is issuing this Notice of Funding Opportunity (NOFO) in response to the declared public health emergency issued by the Secretary, HHS. Please see Determination that a Public Health Emergency Exists Nationwide as the Result of the Opioid Crisis as renewed in Renewal of the Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of the Opioid Crisis.
This NOFO invites applications from early and mid-career investigators (i.e. postdoctoral fellow/associates – associate professor) who strive to expand their research trajectories through the acquisition of new knowledge and skills in the areas of therapeutic drug, biologic, or device development. The development of novel treatments for pain, addiction, and overdose is a vital component to address the ongoing opioid epidemic. This development will be most effective if performed by scientists with experience in translational science. Translation is defined as the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public — from diagnostics and therapeutics to medical procedures and behavioral changes, with translational science representing the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process (https://ncats.nih.gov/translation). Traditional academic training provides deep knowledge of a relatively narrow scientific discipline. While domain expertise is an important characteristic of a proficient translational scientist, a comprehensive understanding of the stages of therapeutic development is also necessary. For many scientists, acquiring needed expertise through participatory involvement in the various fields that are required to compile an investigational new drug (IND), investigational device exemption (IDE), or new drug application (NDA) is extraordinarily difficult given the broad variety of these domains.
This NOFO is designed for early- and mid- career scientists with pain or opioid abuse expertise interested in receiving hands-on experience in translation at an industry laboratory, or an academic or government research center performing therapeutic development activities. The selected research environment should have the requisite capabilities and employ scientists and staff with expertise across the entire translational space for small molecule, biologic, or device development. Areas of requisite capabilities and expertise include, but are not limited to: assay development, high-throughput screening technology, medicinal chemistry, analytical chemistry, advanced informatics, chemistry, manufacturing and controls (CMC), formulation, and toxicology needs assessments, risk assessment, benchtop models, in vitro models, in vivo models, cadaver testing, biocompatibility, shelf-life/stability, sterilization, leachables/extractables, electromagnetic compatibility, quality and data management systems, Phase I, II, III clinical trials, FDA regulatory requirements, human subjects protections, and data and safety monitoring. Potential instructional sites included: academic laboratories, pharmaceutical companies, medical device companies, biotechnologies companies, and non-profit research organizations. translating small molecules, biologics or devices. Career enhancement learning is not limited to these types of settings and this list is provided to facilitate preparation of applications, not an endorsement of these training sites (https://ncats.nih.gov/heal/funding/heal-translational-training-opportunity).
This Notice of Funding Opportunity (NOFO) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this NOFO are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.
Letter of Intent Due Date(s): Although Letters of Intent are usually due 30 days prior to the application due date, for this NOFO, Letters of Intent are due 15 days prior to the application due date.
Application Due Dates: May 22, 2023; July 7, 2023
PAR-23-161 Expiration Date New Date July 8, 2023 (Original Date: May 23, 2023) per issuance of NOT-TR-23-021
Candidates for the K18 award must have a research or health-professional doctoral degree. This award is intended for well-established investigators who have established records of independent, peer-reviewed Federal or private research grant funding. Applicants are not required to have active research grant support at the time of application for this award.
At the time of award, the candidate must have a “full-time” appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.
Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.
After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-18-156 and NIH Grants Policy Statement, Section 188.8.131.52 Temporary Adjustments to the Percent Effort Requirement for more details.