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.

Deadlines:

• 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